Biostatistician Resume Samples

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L Schumm

Lacey

Schumm

586 Breanna Crescent

New York

+1 (555) 637 0820

586 Breanna Crescent

New York

Phone

p +1 (555) 637 0820

Experience Experience

Philadelphia, PA

Biostatistician

Philadelphia, PA

Heidenreich Group

Philadelphia, PA

Biostatistician

Traveling to countries to assist with training and data management in country; assist with capacity development of in-country staff
Creates timelines for statistical project management, with assistance from project leader and statistical managers
Develops and executes statistical programs to perform analyses and prepare data displays
Work with investigators to assist in developing quality procedures for data collection, study design, and statistical analysis
Assist the preparation of clinical development plans from a data management and analysis perspective, including strategic input into research programs
Assist in development of clinical trial protocols, randomization schedules, and in performing associated database-related activities
Manage complex work environment, balancing demands from multiple customers to execute projects

Detroit, MI

Senior Biostatistician

Detroit, MI

Jacobson-Batz

Detroit, MI

Senior Biostatistician

Develop statistical analysis plans, perform exploratory data analysis as necessary and provide data interpretation
Provides assistance in proposal preparation, creation and management of databases
Understand project budget as it relates to project workscope and communicate proactively with management concerning potential changes in workscope
Establish and maintain sound working relationships and effective communication within Biomarkers and Diagnostics Biometrics (BDB) and BDM
Provide internal statistical review requested by Senior Management. e.g in-depth evaluation of statistical methods/data from published literature
None. The worker is not substantially exposed to adverse environmental conditions (such as in typical office or administrative work.)
Work closely with clinical project leads, data manager , regulatory affairs to quantify clinical outcomes in a clear and concise manner

present

New York, NY

Principal Biostatistician

New York, NY

Prosacco, Osinski and Crona

present

New York, NY

Principal Biostatistician

present

Perform or supervise complex statistical analyses and create or provide input to statistical reports – usually in English
Assist the Manager and Sr. Director in defining and maintaining departmental standards, SOPs and working practices
Stay current with new developments in statistics, drug development and regulatory guidance through literature review, conference attendance, etc
Provides input for pooling strategies for submissions and IND updates, and provides statistical input into the Investigator Brochure
Evidence of strong teamwork in order to successfully work with a trial team and project level team members
Leads and manages the technical operations of assigned projects and provides technical guidance and mentoring to the project team
Develop complex analysis strategies, and execute them using efficient programming techniques (software: SAS)

Education Education

Master’s Degree in Biostatistics

Portland State University

Master’s Degree in Biostatistics

Skills Skills

Strong organization and interpersonal skills with the ability to work as part of a diverse team of mental health professionals
Working knowledge of Good Clinical Practices, clinical research, clinical trial processes, and clinical data management practices is desirable
Flexibility with changing priorities, strong attention to detail, ability to work well under pressure and take on unfamiliar tasks
Excellent organizational skills, including ability to multi-task, set priorities and meet timetables while managing several simultaneous projects
Strong knowledge of statistical principles and strong statistical skills
Excellent organizational skills, highly detail-oriented
Strong ability to collaborate across departments and interact with various levels in the organization
Strong SAS programming skills (Proficient in BASE, STAT, MACRO and GRAPH) and understanding of database structures
Excellent written and verbal communications skills, including the ability to explain statistical concepts to laboratory, support staff and to clients
Good knowledge in R is a plus, but not necessary

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Biostatistician Resume Examples & Samples

Experience with quantitative expertise or programming and analysis of epidemiological data using SAS, STATA, SPSS, or other packaged programs
Experience with state-of-the-art data manipulation and statistical methodology and the application of advanced analytical techniques
Experience with a wide variety of data structures, coding schemes, and data sources
Knowledge of coding systems commonly used in health care delivery
Ability to work independently and with collaborators in a team environment
Ability to effectively communicate technical concepts
MS degree in Biostatistics or Statistics and 3+ years of experience with working in bio or medical fields

Biostatistician Resume Examples & Samples

Minimum Master in statistics
At least 5 years experience in pharmaceutical development and clinical research
Strong statistical skills and knowledge of clinical trials methodology
Experience with analysis planning and reporting of clinical trials
Experience in Oncology
High degree of autonomy in performing assigned duties
Able to establish personal relationships with personnel from other line functions

Senior Biostatistician Resume Examples & Samples

Master’s degree in Biostatistics or Statistics
Preferred, Ph.D. in Biostatistics or Statistics
2 years of relevant experience in pharmaceutical or diagnostic company
At least 5 years of experience in pharmaceutical or diagnostic company
FDA or European regulatory experience and in-depth knowledge of regulatory regulations and guidelines
Familiarity with the CLSI guidelines

Biostatistician Resume Examples & Samples

Master’s Degree in Public Health or related discipline and 2 years of experience or PhD in a related field
Proficient in SQL, SAS and R programming; working knowledge of Microsoft Office (e.g., Excel, Word, PowerPoint)
Ability to carry out statistical and HEOR analyses with supervision and prioritize accordingly
Understanding of clinical trial design and epidemiologic research methods; familiarity or experience with health economic and outcomes research methods, preferred
Experience in multiple therapeutic areas is highly desirable
Established ability to work independently or as part of a team in a dynamic environment with rapidly changing demands

Biostatistician Project Lead Resume Examples & Samples

40%Provides leadership in biometrics activities pertaining to study projects. Collaborates with project teams on design and analysis of clinical trials; selects appropriate statistical methods for design of clinical trials and the analysis of clinical study data; provides input into clinical development plans
Strong background and working knowledge of statistical methods that apply to all phases of clinical trials and other study designs. Must have a working knowledge of statistical analysis plans including the report outline, mockup tables, graphs and data listing shells and appendices
Must have a working knowledge of all appropriate relevant regulatory guidance documents (e.g. ICH, FDA and EMEA)
Direct regulatory filing experience is required
Proficiency in SAS and R programming is strongly preferred
Ability to help others understand the broader business and organizational context (inspiring and motivating others)
Demonstrated ability to deliver excellence by integrating planning efforts across departments or organizational boundaries to ensure organizational effectiveness

Senior Biostatistician Resume Examples & Samples

Possess an advanced degree in biostatistics, statistics, or a related discipline (Ph.D. preferred)
Enjoy working in a team environment and collaborating with other bioinformatics scientists and biologists
Comfortable writing code in R (including familiarity with Bioconductor packages), or other scripting languages such as Python
Have some experience with machine learning algorithms
Have previous experience with genomics data analysis in a compute cluster environment
Experience working with at least one existing platform is preferred
Comfortable working in a *ix environment
Knowledgeable or interested in the biology or applications of personalized medicine in the areas of human genetics, immunology, or infectious diseases
Passionate about applying your skills to advance medicine and help patients

Senior Biostatistician Resume Examples & Samples

Master’s degree in Statistics with 5+ years of relevant experience; OR PhD in Statistics or Bioinformatics with 2+ years of relevant experience
Comprehensive understanding of technical principles, theories and concepts in the field of (companion) diagnostic Statistics
Familiarity with methods for the design/optimization/verification of IVD devices under design control (e.g. DFSS, DoE, RSM)
Experience with Software Engineering preferred
Knowledge of statistical software packages (e.g. SAS, R, JMP

Biostatistician Phase Resume Examples & Samples

Exceptional SAS programming skills and understanding of database structures
Strong knowledge of statistical principles, and strong statistical skills
Demonstrated success in a managerial capacity
Solid organizational, interpersonal, and project management skills

Biostatistician Resume Examples & Samples

35%
Reviews project protocols, authors protocol statistical analysis sections, including sample size calculations or simulations
Generates and/or coordinates the creation of randomization schedules and ensures their accuracy
Develops statistical analysis plans for clinical trials or registry studies with fully documented table, listing, and figure shells
Specifies statistical terms, equations for derived variables and algorithms for analysis
Understands and has the ability to use advanced statistical methods
Leads the analysis and reporting of results for clinical trials program or registry database, which may include ISS and ISE, annual reports and/or other regulatory documents
Produces statistical reports as required
Discusses statistical aspects of studies with medical director and regulatory authorities
Liaises with medical writers, interpreting statistical results for input into clinical study reports or other documents
Authors and/or reviews results sections of the clinical study report or other reports
Participates in and/or leads process/quality improvement initiatives
Provides leadership, quality review, and mentoring to less experienced biostatisticians which may include coordinating the work of other biostatisticians and/or programmers
Keeps abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings
Generally 5+ years of relevant pharmaceutical experience

Biostatistician Resume Examples & Samples

Master's Degree in Statistics
Some experience on phase I clinical pharmacology (PK/PD) trials
5+ years of experience in pharmaceutical development and clinical research
Knowledge and expertise in SAS programming

Biostatistician Resume Examples & Samples

Implementing an array of analytic techniques routinely used in the health sciences including sampling, demography, logistic regression, multiple regression, trend analysis, life table analysis, multi-level modeling, weighting techniques, and other chronic disease, behavioral, and social science statistical
Contributing statistical support and consultation on statistical methods, weighting techniques, and analysis of variables from programmatic data
Creating databases and appropriate analysis documentation for dissemination to international study teams
Providing consultation on statistical methods; formulating and solving problems utilizing statistics in the analyses of complex data sets; and serving as an expert on sampling, demography, trend analysis, computer techniques, data weighting, and the utilization of regression analyses
Supporting work by preparing datasets for analysis, conducting and presenting preliminary analyses and participating in discussions with other statisticians and project officers as an integral member of the analytic team
Writing technical data and analysis documentation
Providing technical assistance to countries regarding programmatic data
Traveling to countries to assist with training and data management in country; assist with capacity development of in-country staff
Working closely with mutli-disciplinary teams (epidemiologists, statisticians, other data analysts) to ensure a complete review of the data, as well as providing a thorough understanding of statisical processes and issues that may arise in analysis
Ability to provide deliverables in a timely manner
Ability to effectively communicate with client regarding issues, needs and/or priority setting for projects
Ability to communicate effectively with non-statistically trained scientists and program staff on mathematical and statistical topics
Master’s degree in statistics, biostatistics public health or related field; PhD in same field preferred
Experience as a SAS, Stata, R and/or S+ programmer
Experience working with and aggregating/merging multiple data streams
Experience with basic and complex statistical analyses
Ability to travel internationally to conduct trainings and data quality assurance activities
Candidates must be able to obtain and maintain a government security clearance to be considered for this position
Knowledge of HIV/AIDS prevention and Global Health preferred
Excellent oral and written communication skills, and ability to lead meetings and conference calls required
Strong organizational and interpersonal skills with the ability to work both independently and as a team member are a must
Ability to demonstrate good judgment in selecting methods and techniques for obtaining solutions is a must

Biostatistician Resume Examples & Samples

3+ year of relevant experience
Master's degree in Statistics, Biostatistics or Mathematics with statistical content
Familiarity with PC and VAX computing systems
Working knowledge of SAS; familiarity with other packages
Familiarity with most complex statistical methods that apply to Phase I-IV clinical trials
Experience in effectively managing multiple tasks simultaneously and interact with multi- disciplinary teams.Excellent oral and written communication skills
Pharmaceutical background

Biostatistician Resume Examples & Samples

Master's Degree or Ph.D in Biostatistics or Statistics
Proficiency with most complex statistical methods and modeling that apply to Phase I-IV clinical trials
Strong working knowledge of SAS

Biostatistician Resume Examples & Samples

Develops statistical analysis plans for clinical trials or
Registry studies with fully documented table, listing, and figure shells
Leads the analysis and reporting of results for clinical trials program or registry database, which may include
ISS and ISE, annual reports and/or other regulatory documents
Liaises with medical writers, interpreting statistical
Results for input into clinical study reports or other documents

Principal Biostatistician Resume Examples & Samples

Master’s degree (M.A./M.S.) or equivalent in Biostatistics or related field
3 years related clinical research experience
Knowledge of the drug development process and FDA and ICH Guidelines required
Knowledge of basic statistical design, analysis, and programming techniques utilized in clinical research required
Effective oral and written communication of statistical concepts and results required
Knowledge of one or more statistical software packages used to conduct statistical analyses required
Ability to read, write, speak, and understand English required

Senior Biostatistician Resume Examples & Samples

Consults with Medical Writer, Physician, and Medical Affairs on the interpretation of results from statistical analyses
Contributes to the publication plan. Reviews abstracts, posters, and manuscripts to support Medical Affairs
Leads ad hoc statistical analyses in support of scientific and regulatory interactions
Leads or contributes to departmental process improvement initiatives and development/revision of SOPs
Provides leadership in biometrics activities pertaining to study projects. Collaborates with project teams on design and analysis of clinical trials; selects appropriate statistical methods for design of clinical trials and the analysis of clinical study data; provides input into clinical development plans
Provides specification and reviews draft randomization schedules. Primary SAP author. Determines and provides appropriate sample size calculations for specific objectives of study design
Reviews statistical outputs. Primary author of the statistical methodology section(s) of study reports for study and integrated reports
Responsible for interacting with regulatory authority personnel on clinical trial statistical issues in the design, analysis of clinical trials, design of other study types, and data presentations
Reviews regulatory documents such as CSRs, as well as summary documents
Contributes to the establishment and maintenance of common formats and templates for key Biometrics documentation (e.g., statistical section of protocol, standard CRF pages, Statistical Analysis Plans, Tables, Figures and Listings). Contributes to the design of standards for SAPs
Directs outsourcing activities in collaboration with preferred vendors. Provides strategic and tactical input in the contracting with Global Biometrics preferred providers
M.S. in Biostatistics or closely related field is required
Ph.D. in Biostatistics or closely related field is strongly preferred

Biostatistician Resume Examples & Samples

Strong working knowledge of SAS; familiarity with other packages
Attention and accuracy with details
Experience in effectively managing multiple tasks simultaneously and interact with multi- disciplinary teams
Prior experience in Pharmaceuticals
Master's Degree in Statistics, Biostatistics or Mathematics with statistical content

Senior Biostatistician Resume Examples & Samples

Ensures all statistical work is processed on time to appropriate quality levels
Reviews case report forms to ensure that protocol objectives are met and project standards are maintained
Prepares documentation/specifications to support SAS code for analysis programs
Verifies statistical programs, data sets used and statistical results in regulatory documents and other reports
Develops SAS programs as necessary to perform planned or ad hoc analyses and prepare data displays
Provides statistical interpretation of results and explains statistical methodology to team members
Supplies statistical input for regulatory submissions and in response to health authority questions
Provides support for publication of clinical trial or registry database results
Assists in the Development of SOPs pertaining to Biostatistics and SAS programming, consistent with FDA and ICH regulations and guidelines
Helps with the recruitment of biostatisticians
Presents and discusses the statistical aspects of clinical trials to professional organizations, e.g. FDA reviewers, or less technically oriented audiences
Ph.D. in Biostatistics or closely related field is preferred

Senior Biostatistician Resume Examples & Samples

Specifies statistical terms, equations for derived variables and algorithms for analysis with some guidance as necessary
Supplies statistical input for regulatory submissions and in response to health authority questions with some guidance
Participates in the Development of SOPs pertaining to Biostatistics and SAS programming, consistent with FDA and ICH regulations and guidelines
Ability to present and discuss the statistical aspects of clinical trials to professional organizations, e.g. FDA reviewers, or less technically oriented audiences
Generally 3+ years of relevant pharmaceutical experience

Biostatistician Resume Examples & Samples

MS with at least 7 years relevant experience, or equivalent
Experience programming in SAS
Understanding of ICH GCP as well as general knowledge of industry practices and standards
Proficiency in R programming language and other statistical software, including EAST
Experience with CDISC, including SDTM, ADaM, CDASH
Performs statistical analyses on data from clinical trials and observational studies as needed
Writes the statistical sections of clinical trial protocols, while consulting with internal and external experts
Contributes to or prepares statistical analysis plans
Collaborates with Data Management, Clinical Development and Clinical Operations on design of eCRFs
Provides statistical input on conduct of ongoing trials
Reviews stratification/randomization schema
Collaborates with Statistical Programmers on summary and analysis of trial data. Writes ADS and ad hoc analysis specifications
Contributes to and performs statistical analyses to support clinical study reports and other regulatory documents as needed e.g. DSURs, etc
Participates in other activities and meetings to support Biostatistics and the Development Team as needed

Senior Biostatistician Resume Examples & Samples

Provide statistical input into the clinical development of drugs for treatment of Alzheimer’s disease and mental health
Work with the clinical team in designing clinical studies, leading/authoring the statistical analysis plan
Ensure accuracy and facilitates the implementation of statistical analyses
Provide statistical input to the clinical study report
Perform statistical functions for submission related activities
Providing input in the preparation of scientific presentations and manuscripts
Participate in process improvement, training, standards development and enhancing statistical technical expertise
Interface with Biostatistics staff, clinical teams, and associated working groups
Be involved in communication with clinical therapeutic area members, SAS programming, clinical data management, clinical trials management, regulatory affairs, clinical communications, clinical pharmacology, medical writing, and quality management
Work with external partners including key opinion leaders in the neuroscience area, may work with external regulatory agencies and advisory committees, and contract research organizations
A minimum of a Master’s Degree in Statistics (or Computer Science or Mathematics with pharmaceutical experience) with 4+ years of experience or a PhD in Statistics or related field with at least 2+ years of experience is required
Knowledge of SAS programming and at least some other significant statistics software (e.g., R, S-Plus, PASS) is required
Experience with clinical trials and knowledge of regulatory guidance are required
Neuroscience industry experience is preferred but not required
Demonstrated written and oral communication skills and ability to work within a team and work independently are required
Other important requirements include: interdependent partnering; building strategic working relationships; mastering complexity; and good decision making capability

Senior Biostatistician Resume Examples & Samples

Provide statistical input into the clinical development of drugs for treatment of cancer
Work with the clinical team in designing clinical studies, leading/authoring the statistical analysis plan, conducting the statistical analysis, and providing statistical input to the clinical study report
Provide input in the preparation of scientific presentations and manuscripts
Liaise with other statisticians within the organization, building working relationships with therapeutic area leaders, internal SAS programmers, clinical trial managers, and personnel from regulatory affairs, medical writing, and other disciplines as needed
Work with external partners including key opinion leaders in the oncology area, may work with external regulatory agencies and advisory committees, and contract research organizations
A Master’s degree in Statistics or related field with at least 4 years of clinical data analysis experience is required OR a PhD in Statistics or related field is preferred
Working knowledge of statistical software such as SAS, R, or SPlus is required
Experience and knowledge of Good Clinical Practices and regulatory requirements for clinical drug development, including the conduct of clinical trials is preferred
Excellent verbal and written communication skills, including formal presentation skills are required
Excellent analytical skills are required
Experience presenting to technical and lay groups at public meetings is preferred
Advanced knowledge of statistical methodology including experience with modeling and simulations is preferred

Senior Biostatistician Resume Examples & Samples

Appropriate research and application of statistical methodology is essential
Co-authorship of publications and presentations is also expected
A Master’s degree in Statistics or a related field and a minimum of 4 years of experience or a PhD in Statistics or a related field and a minimum of 2 years of experience is required
Proficiency of R and/or SAS statistical software is required
Demonstrated strong written and oral communication skills are required
Demonstrated experience managing multiple projects concurrently is required
Knowledge of nonlinear modelling, Bayesian methodologies and generalized mixed modeling is desirable

Biostatistician Resume Examples & Samples

Collaborating with researchers on experimental design, data analysis, interpretation and communication of data evidence for research, development, and/or marketed product needs in Janssen R&D or other J&J organizations
Appropriate application of statistical methodology is essential
Be constantly eager to expand their statistical, communications, and computing expertise
Enjoy the process of building long-term collaborative relationships, be at ease with either a non-rigid or rigid structure to projects, and be organized in handling numerous projects simultaneously
Participation in the external professional community is expected as well
A Master’s degree in Statistics or related Quantitative Sciences field and is required. A PhD in Statistics or a related Quantitative Sciences field is preferred
Proficiency in R, SAS statistical software is required
Knowledge of linear models and multivariate analysis is required
Some exposure to modern data analysis techniques such as data visualization, robust statistics and analysis of high-dimensional data is preferred

Senior Biostatistician Resume Examples & Samples

A minimum of a Master’s Degree in Statistics or related field combined with 2+ years of experience is required
A PhD in Statistics is strongly preferred
Basic knowledge of SAS programming and at least some other significant statistics software (e.g., S-Plus, PASS) is required
Oncology industry experience is preferred but not required
Strong written and oral communication skills are required
The ability to work independently is required
The position is located in La Jolla, CA and may require up to 10% (international/domestic) travel.Biostatistics

Biostatistician Resume Examples & Samples

Designs and develops statistical analysis applications and methods for research
Analyzes and interprets data for various research grants
Stays informed of and writes computer programs to implement new statistical techniques
Performs analysis of epi data including GxG and GxE
Demonstrates ability to comprehend genetic analysis
Master's degree in Statistics, MIS, or a closely related field
A Bachelor's degree and two years of directly-related biostatistics experience is considered equivalent to a Master's degree

Senior Biostatistician Resume Examples & Samples

Required: Master's Degree in Statistics, Biostatistics or a closely related field
Required: At least three years of experience as a biostatistician in a medical and health related setting
Excellent computer programming skills, especially with SAS programming
Excellent interpersonal and communications skills in both written and spoken English

Senior Biostatistician Resume Examples & Samples

Ability to work both independently & collaboratively
Excellent interpersonal and oral and written communication skills
Attention to detail and experience working with large local and national administrative datasets
Proficiency in SAS and knowledge of other statistical and geographic software programs (e.g. STATA, R, ArcGIS)
Knowledge of panel, longitudinal and survival analysis methods
Interest in kidney disease and hypertension
Ability to select, apply, and evaluate new statistical methods
Comfort preparing documents and presentation using MS Word, Excel, and PowerPoint

Biostatistician Resume Examples & Samples

Performs statistical analysis of data using advanced statistical procedures using statistical software (SAS and R)
Oversees data management (auditing, editing & analysis) and quality control of study databases. Day-to-day oversight of study activities, communications with sites to coordinate and document resolution of study issues
Participates in project development from beginning to end. Participates as a member of a multi-disciplinary team of programmers and researchers to ensure deliverables are completed efficiently
Data analysis using advanced statistical procedures in biomedical applications
Writing reports and assisting with preparation of manuscripts
Oversight of study databases
Management of data and project staff (as applicable)

Biostatistician Resume Examples & Samples

Plan and carry out biostatistical data analyses, including generation of analysis data sets and design and generation of tables and figures reporting analysis results
Contribute to writing and reviewing drafts of reports, posters, and manuscripts, including writing up interpretation of analysis results and description of statistical methods used
Create and maintain documentation of statistical methods and programming code
Create analysis datasets for scientific manuscripts and presentations and public use databases, including associated data dictionaries
Identify potential problems with study data and collaborate with research team to resolve issues encountered
Assist in preparing materials for and participate in investigators' meetings, Steering Committee meetings, Data and Safety Monitoring Board meetings, staff meetings, etc
Complete other as-needed data programming and analysis
Attend staff meetings and provide updates on status of reports, papers, and other work responsibilities
Good organizational, written and verbal communication skills in the preparation and presentation of results

Biostatistician Resume Examples & Samples

Maintain and update existing research databases as needed using SAS or Stata
Produce descriptive reports, including tables and graphs
Generate figures and draft text as needed for manuscripts, grants, and reports
Perform quality assurance on data
Write code to perform statistical and epidemiological analysis for research questions, manuscripts and contract/grant submissions
Work collaboratively with other analysts/study coordinators/staff
Other logistical or administrative research support including literature searches, powerpoint and poster creation

Biostatistician Resume Examples & Samples

Higher degree in computational biology or computer science
Experience working with unstructured text data
Experience working with electronic health records training in Biomedical Informatics
Demonstrated excellence in at least one area of expertise, which may include coordinating studies; statistical methodology such as missing data, survival analysis, statistical genetics, or informatics; statistical computing; database design (e.g., expertise in RedCAP or MySQL); graphical techniques (e.g., expertise in Illustrator)

Biostatistician Resume Examples & Samples

Working knowledge of biological research techniques and some background in immunology
Familiarity with specific types of immunological assays such as flow cytometry, Luminex, and/or TCRseq
Ability to work with SQL databases

Radiology Biostatistician Resume Examples & Samples

Skills in descriptive analysis, modeling of data, and graphic interfaces
Ability to manage and prioritize multiple projects to ensure on-time delivery with meticulous quality
Ability to become well-versed with relevant medical and imaging concepts and terminology

Biostatistician Resume Examples & Samples

Excellent verbal and written communication skills are desired in order to provide feedback to members of the scientific community to facilitate the description of data, effectively provide documentation and specifications to co-workers during research development, and contribute the drafting of scientific literature and grant applications using results from analyses
Previous experience working in an academic environment is desired. The work will take place in a dynamic environment where specifications often change rapidly in response to demand, so the candidate must be able to be flexible. The successful candidate will work at the Stanford University in Palo Alto, California. Complies with and supports University and government health and safety regulations and policies
The role will require knowledge of a wide array of data, including census, human mortality database, NHANES, and available health claims data to accommodate the wide array of potential investigators who will seek support
The range of analyses will also require someone with a large “tool-kit” as the work will demand both clinical epidemiology and a host of “big data” skills working with large population sets and will also demand ability to work in all of the coding languages in major use
The role of consultant for PHS investigators will also demand the ability to work with both extremely sophisticated investigators as well as neophytes; both interpersonal skills as well as the ability to gauge the clients need will be essential
Master's degree in biostatistics, statistics or related field and at least 5 years of experience or Ph.D. in biostatistics, statistics or related field and at least three years’ experience
Demonstrated excellence in at least one area of expertise, which may include coordinating studies; statistical methodology such as missing data, survival analysis, statistical genetics, or informatics; statistical computing; database design (e.g., expertise in

Biostatistician Resume Examples & Samples

College graduate in statistical discipline, computer science or related field, or related experience
Has high level knowledge of drug development as it pertains to biostatistics; has the ability to apply drug development knowledge during production of high quality statistical analyses
Strong hands-on experience with clinical trial and pharmaceutical development
Strong experience with data and production of TLGs
Strong programming and logic skills
Experience in pharmaceutical or CRO industry preferred
Strong SAS programming, SAS base, SAS macro experience
Thorough knowledge and understanding of clinical data preferred
Familiarity with graphical software (e.g., SigmaPlot)
Strong resource for biostatistics; willing to guide others in a variety of biostatistical techniques
Excellent scientific writing skills
Proficiency with MS Office applications
Familiarity with ISO 9001:2008 requirements
Practices good internal and external customer service
Responsible for implementation and execution of high quality client statistical analyses
Demonstrates strong understanding of ICH guidelines, as applicable to statistics
Creates statistical training exercises, trains new biostatisticians, and serves as a mentor
Trains via self-study and self-practice independently and explores advanced topics related to biostatistics and/or drug development
Utilizes System Development Life Cycle (SDLC) for statistical deliverables
Interacts directly and independently with client to coordinate all facets of the project; competent communicator
Provides high level of support to the programmers and medical writers on all statistical matters according to client requirements
Provides advanced input into statistical sections of the protocol,

Biostatistician Resume Examples & Samples

Master's degree in Biostatistics, Statistics, Applied Mathematics or related field required
Ph.D. in Biostatistics, Statistics, Applied Mathematics or related field preferred
Minimum of three years of clinical trial experience
Prior experience in either pharmaceutical or biotechnology industries preferred
Must have prior experience with SAS Programming
Ability to work in a team environment with medical personnel, clinical

Biostatistician Researcher Resume Examples & Samples

Evaluate and analyze healthcare claims data using accepted statistical and biostatistical techniques
Investigates, analyzes, and evaluates complex statistical and programming issues. Determines proper methodology, testing standards, and evaluation process for research projects. Recommends and develops statistical approaches for use in analysis
Prepares detailed specifications for study databases and analysis files, consistency checks, tables, and figures; communicates requirements to the programming group
In collaboration with the research team, contributes to the design of research studies, develops analytic plans, conducts statistical analysis, performs quality control, and interpret the results; communicates with clients regarding statistical analysis issues
Plans statistical programming activities and schedules to provide project team with guidance on data management and data analysis timelines for projects
Leads and supports initiatives to improve efficiency and standardization in research analytics

Biostatistician / Hours / Day / Bwh Renal Resume Examples & Samples

Independently derives clinical study databases and performs validation analyses of ongoing clinical studies
Collaborates with Principal Investigator to develop and perform statistical analyses (including planning, programming, analysis, interpretation and writing of results) for investigational protocols, subgroup and post-hoc projects and registry databases ending with preparation of manuscripts, abstracts and presentations at scientific meetings
Determines and/or verifies correct statistical testing to be performed in each analysis request
Rearranges data in SAS in a format that allows for accurate use as well as possible integration and pooling across studies
Oversees the compilation and organization of data and results for transmission to investigators, sponsors, and other collaborators
Assures maintenance of an up-to-date electronic archive recording data requests, statistical analyses, results, and data transmissions performed
Master’s degree in biostatistics, statistics, or related field with training in design and analysis of observational and experimental studies
Minimum 3 years of related experience
High proficiency in statistical computing including logistic regression, linear regression, Cox proportional hazards, and mixed effects regression for repeated measures designs; SAS experience strongly preferred
High degree of computer literacy
Sound analytical and organizational skills
Requires excellent oral and written communication skills
Must be able to logically and effectively structure tasks and set priorities
Ability to identify problems and troubleshoot solutions
Demonstrated ability to analyze data statistically and to logically present it
Ability to work independently as well as part of a team
Possess managerial skills in order to interact with both with statistical staff, sr. Investigators and other members of the internal and external research group
Ability to prioritize assignments, multi-task, make decisions based upon sound principles, and independently problem solve
Ability to develop novel ways to coordinate, manage and report data if required by new trials

Biostatistician Resume Examples & Samples

Advanced SAS programming skills for data manipulation (macros, proc SQL, data and proc steps, merging, use of first & last from proc sort, removal of duplicates, running totals, merging, etc). Ability to work with multiple data sources and large datasets (millions of records)
Basic applied statistical skills (Chi-square tests, Fisher’s exact test, t-tests, Wilcoxon rank sum tests, paired tests, linear & logistic regression, Cox proportional hazards regression, Kaplan Meier survival plots)
Excellent written and oral communication skills. Ability to clearly explain and define algorithm rules. Ability to clearly explain and write statistical results in easy to understand terms
Excellent time management skills and ability to prioritize. Must be able to make necessary decisions to meet deadlines
Ability to work in a fast paced team environment. Positive attitude in an ever changing environment is a must

Biostatistician Resume Examples & Samples

Provide statistical support in the design and analysis of surveys, randomized controlled trials, and risk factor assessments including modeling of data
Develop statistical and mathematical models to describe findings and describe current trends and changes in trends
Provide statistical input in the study design phase and analysis phase, as well as in careful review of the end product, focusing on appropriateness of statistical methods and validity of conclusions
Establish and track time schedules for completing various phases of system development
Design and conduct methodologically sound research and evaluation studies using univariate, bivariate, multivariate and other statistical testing approaches as appropriate
Independently provide computer programmer and other information technology support services to satisfy the overall operational objectives of the CDC
Provide statistical support to the CDC. This support shall include overseeing data cleaning and quality, the creation of datasets, working with CDC scientists to select analytic approaches appropriate to the objectives of the study, and conducting analyses using a variety of statistical techniques and software
Participate in the interpretation of study results and manuscript preparation
Provide programming support, which shall include designing and maintaining customized databases for data entry and tracking, querying custom datasets for analysis, supporting and troubleshooting users, developing new functionality as indicated, developing a detailed understanding of existing databases including but not limited to Project, and running descriptive statistics and other computations as requested
Track, monitor, analyze, and report data from epidemiological surveillance and outbreaks
Merge, integrate and pool data across different sources
Perform data management and analysis
Compile and organize data and assure accuracy
Contribute to the writing and editing of reports, manuscripts and other documents
Bachelor's Degree in Statistics, Public Health or related field from an accredited college or university required, equivalent experience will be considered in lieu of degree
At least three (3) years of experience in data management and statistical analysis required
Efficient use of statistical software packages such as SAS, Access, Excel, EpiInfo
Excellent data management skills
Knowledge and experience in assuring data quality and validation and possess capabilities in basic and complex data analysis
Strong oral and written communication skills, as the core duties require regular interaction, both direct and in writing, with staff epidemiologists, health scientists, and programmers
Ability to prioritize assignments and multi-task
Ability to work systematically and independently
Ability to prioritize and effectively manage several projects simultaneously
Ability to draft plans to resolve inaccuracies or other problematic situations
Knowledge of study design and ability to identify and explore potential sources of bias and confounding and a thorough understanding of statistical methods including but not limited to linear, logistic, and conditional logistic regression models
Ability to research, learn and provide innovative and original thinking with regards to study design and in the use of established and new statistical methods is also required
Prior CDC experience preferred

Principal Biostatistician Resume Examples & Samples

Maintains a good working knowledge of clinical drug development, ICH and other regulatory guidelines, and biostatistics in order to effectively serve as a statistical department resource, mentors biostatisticians on job skills, oversees or develops training plans or materials for Biostatistics associates, conducts training sessions, or otherwise trains new hires and enhances the skills of existing personnel
Collaborates in the process of protocol development by choosing an appropriate study design, including statistical methodologies, calculating necessary sample size to achieve a pre-specified power, and writing the statistical section of the protocol. Sample size calculations may require some literature search to ensure that the study assumptions are correct
Writes and reviews Statistical Analysis Plans (SAPs) based on the protocol, including development of well-presented mock-up displays for tables, listings, and figures. Collaborates with sponsor. Creates or reviews programming specifications for analysis datasets, tables, listings, and figures
Directs the activities of other Biostatistics personnel on assigned projects to ensure timely completion of high quality work. Provides independent review of project work produced by other statisticians in the department
Provides input to Standard Operating Procedures (SOPs) development and review
Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings
Participates in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development and serving as an independent non-voting statistician
Discusses time estimates for completion of study related activities with the Lead Statistician or Biostatistics management and proactively communicate to the Lead Statistician or Biostatistics management any difficulties with meeting these timelines. Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met. Identifies out of scope tasks and escalates to management
Displays willingness to work with others and assist with projects and business unit initiatives as necessary to meet the needs of the business

Senior Biostatistician Resume Examples & Samples

Writes and reviews Statistical Analysis Plans (SAPs) based on the protocol, including development of well-presented mock-up displays for tables, listings, and figures. Collaborates with sponsor
Creates or reviews programming specifications for analysis datasets, tables, listings, and figures
Conducts and participates in review and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP
Generates and/or reviews randomization schedule(s) to ensure there are no errors present and sponsor and protocol requirements are met. Performs ongoing monitoring of actual randomization scheme applied by IVRS/IWRS
Academically well qualified: MSc or PhD in Statistics or Medical Statistics
Extensive experience in clinical trials and the drug development process preferably within a CRO and/or Pharmaceutical environment
Ability to apply knowledge of statistical design, analysis and programming techniques used in clinical trials
Strong SAS experience

Biostatistician Resume Examples & Samples

Assists in the process of protocol development by choosing an appropriate study design including statistical methodologies, calculating necessary sample size to achieve a pre-specified power, and writing the statistical section of the protocol. Sample size calculations may require some literature search to ensure that the study assumptions are correct
Participates in project teams as Biostatistics representative, interfacing as necessary with other departmental project team representatives
Supports business development activities by attending sponsor bid defense meetings
Reviews SAS annotated CRFs, SAS database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis
Conducts and participates in verification and quality control of project deliverables, ensuring that output meets the expected results and is consistent with analysis described in SAP
Discusses time estimates for completion of study related activities with the Lead Statistician or Biostatistics management and proactively communicate to the Lead Statistician or Biostatistics management any difficulties with meeting these timelines. Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met
Provides statistical programming support as needed
Ensures proper study closeout by documenting and archiving study related materials according to Standard Operating Procedures (SOPs), and/or sponsor instructions
Generates randomization schedule(s) ensuring there are no errors present and sponsor and protocol requirements are met. Provides support for ongoing monitoring of actual randomization scheme applied by IVRS/IWRS

Biostatistician Resume Examples & Samples

Assists in the development of Statistical Analysis Plans (SAPs) based on the protocol, including development of well-presented mock-up displays for tables, listings, and figures. Collaborates with sponsor if required
Discusses time estimates for completion of study related activities with the Lead Statistician or Biostatistics management and proactively communicates to the Lead Statistician or Biostatistics management any difficulties with meeting these timelines. Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met
Assists the Lead Biostatistician in development of randomization schedule(s) to ensure there are no errors present and sponsor and protocol requirements are met

Senior Biostatistician Resume Examples & Samples

Acts as the lead or back-up statistician for multiple projects with any level of complexity
Acts as the primary contact with the sponsor for all biostatistics related activities on assigned projects
Writes and reviews Statistical Analysis Plans (SAPs) based on the protocol, including development of well-presented mock-up displays for tables, listings, and figures

Biostatistician Resume Examples & Samples

Support statistical needs of Clinical Research and other project teams. Consult with project teams and apply statistical expertise to ensure the scientific validity and proper design of studies, prepare written summaries for use by regulatory agencies or project teams
Support clinical trial data management activities to include; database setup, CRF (Case Report Form) and data entry screen design; editing and auditing; query generation and tracking; audit trail; CRF review and edit checks; coding; generation of listings, reports, and tables; validation; and statistical analysis of data
Expertise in SAS is required. Minimum 2-4 years of experience in full time SAS programming in the biomedical industry. Solid knowledge of BASE SAS, SAS/STAT, SAS MACROs, SAS ODS, and SAS/GRAPH
Expertise in Good Clinical Practice (GCP) standards as applied to Clinical Trial Data Management is required
Familiarity with Excel, MS Access and Visual Basic would be a plus
Statistical expertise in programming of common statistical methods in clinical trial analysis is required. Expertise in multivariate logistic modeling and sample size calculations is a plus. Familiarity with in vitro diagnostic (IVD) immunoassays and IVD clinical trial statistics (e.g. ROC curves, PPV, NPV) is a plus
Must be highly-motivated, team-oriented, and organized with a strong attention to detail. Must have the ability to write documentation and understand, interact and communicate effectively with others
The qualified candidate should have a degree in field of biostatistics or equivalent and experience in within a pharmaceutical or medical device environment; a Bachelor's degree in field with 5+ year experience, Master’s degree in field with 3+ year experience, or Doctoral degree in field with 0-2 year experience

Principal Biostatistician Resume Examples & Samples

Proficient in up-to-date statistical knowledge/applications and advance expertise in analytic aspects
Solid experience in leading statistical analytic support for multiple trials
Proven knowledge in drug development
Deep knowledge of data architecture
Good interpersonal and communication skills

Principal Biostatistician Resume Examples & Samples

Accountable for developing RAPs for multiple studies which are aligned to a project or indication MAP and includes statistical analysis and reporting details for the statistical programmer to implement (specifications for derived variables, specification and development of statistical computing solutions using statistical software for inferential statistical analyses, tables and listings templates, modern statistical graphics for the FIR and CSR) of Phase I-IV clinical trials and performing these tasks with a high level of independence. 2. Accountable for RAPs execution for multiple studies including the RAP meetings with necessary CTT members, for reporting activities, for exploratory analyses/ graphics and for additional analyses to support publications
Accountable for CSR deliverables including the sections of detailed statistical methods and as one of authors signing the CSR. 4. Ensure that documents, specifications, programs/macros are consistent within an indication or a clinical project and comply with CSU/project/company standards/processes and provide input to the study protocol, CRF, data structures, VAPs, specifications of analysis datasets, pooled datasets, listings, tables and figures, CSR for Phase I-IV clinical trials. 5. Ensure high quality for all deliverables and follow the processes. 6. Ensure to deliver agreed timelines for statistical deliverables across multiple studies (RAP, Tables, Listings and Graphs, CSR). 7. Establish and maintain efficient interfaces with internal and external customers with support of IIS management. 8. Support statistical research by providing advice and contributing to computational aspects
Provide statistical analysis solutions when exploratory analyses are required. 10. Ensure operational excellence by giving input to standard programs (which can be re-used) in collaboration with the statistical programmers and statistical scientists for all studies within an indication or a clinical project. 11. Help with giving input to develop computational environment / systems which are GxP compliant. 12. Identify opportunities in advancing efficiency in computational analytic tactics. Participate in respective change initiatives. 13. Maintain knowledge of statistical / numerical analysis literature. 14. Provide input to project-level standards. 15. Support the Statistical Scientist in protocol writing by providing statistical computational solutions for scenarios simulations and sample size calculations

Principal Biostatistician Resume Examples & Samples

Accountable for developing RAPs for multiple studies which are aligned to a project or indication MAP and includes statistical analysis and reporting details for the statistical programmer to implement (specifications for derived variables, specification and development of statistical computing solutions using statistical software for inferential statistical analyses, tables and listings templates, modern statistical graphics for the FIR and CSR) of Phase I-IV clinical trials and performing these tasks with a high level of independence
Accountable for RAPs execution for multiple studies including the RAP meetings with necessary CTT members, for reporting activities, for exploratory analyses/ graphics and for additional analyses to support publications
Accountable for CSR deliverables including the sections of detailed statistical methods and as one of authors signing the CSR
Ensure that documents, specifications, programs/macros are consistent within an indication or a clinical project and comply with CSU/project/company standards/processes and provide input to the study protocol, CRF, data structures, VAPs, specifications of analysis datasets, pooled datasets, listings, tables and figures, CSR for Phase I-IV clinical trials
Ensure to deliver agreed timelines and high quality for statistical deliverables across multiple studies (RAP, Tables, Listings and Graphs, CSR), following the processes and standards
Represents IIS at trial level internal/external meetings for strategic statistical scientific inputs
Establish and maintain efficient interfaces with internal and external customers with support of IIS management, integrating statistical methodology group as needed
May contribute to statistical scientific evaluation of in-licensing opportunities
Support statistical research by providing advice and contributing to computational aspects as well as contributing to the statistical scientific content for internal decision boards/regulatory/submission documents: Briefing Books, Decision Criteria, trial design(s), respond to trial specific HA questions
Provide statistical analysis solutions when exploratory analyses are required
Ensure operational excellence by giving input to standard programs (which can be re-used) in collaboration with the statistical programmers and other statisticians for all studies within an indication or a clinical project
Help with giving input to develop computational environment / systems which are GxP compliant
Identify opportunities in advancing efficiency in computational analytic tactics. Participate in respective change initiatives
Maintain knowledge of statistical / numerical analysis literature
Effectiveness of communication
Effectiveness and relevance to trial research objectives of the computational tools used
Contribution to the exploratory analyses as and when required
Contribution to clinical project level standardization with respect to statistical computation and programming
Contribution to operational excellence and to Strong IIS team dynamics
Proficient knowledge of / experience with SAS/ R/ Splus or any other business or research analytic software

Senior Biostatistician Resume Examples & Samples

Provide statistical consultation to clinical team and support decision making process by providing adequate information
Track clinical trial/allocated project activities and milestones
Ensure timeliness and adequate quality of all Biostatistics and Statistical Reporting (B&SR) deliverables for the assigned trials
Follow processes and adhere to Novartis and project specific standards as well as Health Authority requirements (SOPs, Master Analysis Plan, GCP, and regulatory guidelines)
Participate in or lead non-clinical project activities as needed
Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and B&SR team. Meet established KPIs. Timely and high quality completion of Biometrics deliverables according to established objectives. Novartis is an Equal Opportunity Employer

Principal Biostatistician Resume Examples & Samples

Working knowledge of regulatory guidance in pharmaceutical or device product registration is required
Knowledge and skills of SAS and PC application software such as sample size determination are required
Direct experience in submission or regulatory interaction is a plus
Experience in the UNIX setting as well as with other statistical software such as S-plus/R is a plus

Principal Biostatistician Resume Examples & Samples

Bachelor’s degree with 7 years’ of experience in research or data analyst role or Master’s degree with 5 years’ of experience in research or data analyst role, or Ph.D. degree with 2 years of experience in research or data analyst role
Must have a degree in Statistics / Biostatistics
SAS programming experience (i.e. Base SAS/STAT, Excel, and ASCII)
Ph.D. degree highly preferred
Expertise in statistical principles, methods, and procedures and the ability to instruct others in these areas
Management or direct supervisory experience
Ability to assess and allocate resources across multiple projects, motivate and develop a staff of biostatisticians
Ability to read, analyze, and interpret the most complex documents
Ability to comprehend and apply principles of adaptive/bayesian study design, advanced calculus, modern algebra, and advanced statistical theory. Ability to work with concepts such as limits, quadratic and differential equations, proofs of theorems, probability distributions and sampling theory
Ability to create novel statistical techniques as needed and to demonstrate the mathematical validity of these techniques
High degree of initiative and self-motivation
Demonstrated ability to identify and adapt to shifting priorities and competing demands
Strong attention to detail and accuracy
Strong time management and prioritization skills for management of multiple projects
Organizational savvy, ability to navigate in a large, global organization

Biostatistician, Temp Resume Examples & Samples

Master’s degree in Biostatistics, Statistics, Applied Mathematics or related field required
Must be able to exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
Knowledge of statistical and clinical trial methodology is required
Attention to detail with high quality outputs
Must have excellent verbal, written and communication skills
Ability to work in a team environment with medical personnel, clinical monitors, data managers, clinical programmers, statisticians, and statistical programmers
Ability to prioritize, multi-task, and maintain attention to detail
Strong analytical skills and ability to gather and understand client requirements

Biostatistician Resume Examples & Samples

Experience with standard statistical methodologies
Experience in the development of statistical plans
Working knowledge of SAS, and other programming packages
Experience in analyses of observational studies or clinical trial studies
Experience with data extraction, cleaning, and analysis
Excellent analytical, problem solving, communication and organization skills
Flexibility with changing priorities, strong attention to detail, ability to work well under pressure and take on unfamiliar tasks
Ability to work in a collaborative environment, drive to learn and improve skills
Ability to communicate statistical interpretation to non-scientists
At least 2 years experience in pharmaceutical, academic, or managed care setting
Ph.D in statistics or MPH or equivalent degree
Ability to understand and develop statistical and models using the latest tools and methodologies

Principal Biostatistician Resume Examples & Samples

Oversee the statistical planning, study design, analysis, reporting and communication of data and analyses of clinical studies from all phases of clinical development and post-approval
Utilize standard statistical methods including but not limited to parametric and non-parametric analysis, survival analyses, longitudinal data analysis, logistic regression, methods used in handling missing data, MMRM, GEE, and multiple testing procedures
Work with existing knowledge of SAS, including familiarity with SAS/GRAPH, and SAS/MACRO
Apply standard and complex statistical methodology and simulation methods
Utilize knowledge of industry standards for database design (CDISC: SDTM, ADaM)
Communicate statistical concepts and interpretations to non-scientists
Guide data management and programming in developing standards for building databases, edit checks, and statistical programming for data analyses
Manage statistical and programming activities of CROs
MS in statistics, mathematics or related field with at least 7 year experience or PhD with 5+ year experience in biotech/pharma or CRO
Flexibility to deal with multiple priorities, detail-oriented, and ability to work well under pressure
Ability to work in a collaborative environment and a drive to learn and improve skills
Strong analytical skills and demonstrated experience in gathering, interpreting and analyzing data
Strong statistical experience in clinical research and drug development
Strong communication and interpersonal skills; previous experience interacting with and directing cross-functional teams
Knowledge of R programming is a plus
NDA experience is preferred
Overnight travel ~10%

Biostatistician Resume Examples & Samples

No prior pharmaceutical/biotechnology experience required
MS with 2 years experience in clinical trial setting
Demonstrates organizational skills; able to prioritize workload
Effective communicator: able to explain methodology and consequences of decisions in lay terms
Effective team player; willingness to go the extra distance to get results, meet deadlines, etc
Able to be flexible when priorities change

Biostatistician Resume Examples & Samples

Provide guidance and instruction on appropriate statistical evaluation methods and practices
Supply appropriate statistical technical input when requested, including complaint investigations and justifications/explanations for regulatory agencies
Create suitable research designs and methods and formulate realistic plans for data analysis
Effectively communicate technical results to a wide variety of clients
Clearly summarize findings in oral, written, and graphical forms
5+ years of statistical analysis of biological data and SAS programming experience in a biotech industry environment

Senior Biostatistician Resume Examples & Samples

Works collaboratively with Statistical Programmers, Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for statistical data analysis and reporting
Directs internal and external teams across multifunctional project or functional areas, leads initiatives to gather, organize, and analyze data from different sources such as virology, Case Report Forms, and patient tracking; and works with management and Human Resources to satisfy short-term staffing needs
Is expected to oversee and contribute to the completion of all technical and operational statistical activities for a group of clinical trials for a compound/indication or equivalent through management of internal and external resources
Provides senior level review of various technical documents
Excellent verbal and written communication skills and interpersonal skills are required
Offers advice to others within the company to help make better decisions and resolve problems
Ability to examine issues from various perspectives and apply appropriate concepts to address situations
Must be able to determine the functions most critical to company success and to support priorities within functional area
Addresses obstacles and difficulties of clients in order to meet goals
Can pull together highly effective teams and create a clear sense of direction
8 years of industry experience in the statistical analysis of biomedical data using SAS® software and a BS degree in Biostatistics or equivalent
4+ years of industry experience in the statistical analysis of biomedical data using SAS® software and an MS degree in Biostatistics or equivalent
2+ year of industry experience in the statistical analysis of biomedical data using SAS® software and a PhD degree in Biostatistics or equivalent

Senior Biostatistician Resume Examples & Samples

Works collaboratively with Clinical Research, Statistical Programmers, Biostatisticians, , Clinical Data Managers, Biomarker Scientists, Bioinformatics, and other Clinical, Global Drug Safety, Regulatory and Project Management
Staff to meet project deliverables and timelines for statistical data analysis and reporting
Works concurrently on 3-4 assigned components of a clinical trial / project as well as other tasks as assigned by supervisor
Demonstrates sound judgment in determining whether a situation calls for negotiation or problem solving
Reacts quickly and proactively to accommodate business need (e.g., ability to transition rapidly between projects)
Balances team’s needs or priorities with one’s own priorities
Includes others in discussion to gain common understanding and agreement
Clearly understands goals and expectations for self and others within the project team matrix
Communicates highly complex or technical information clearly so others can understand
Negotiates with customers (e.g., Clinical) specifications, delivery dates, review periods and revisions for statistical tables, listings, and figures
2+ years with PhD degree in Biostatistics or equivalent

Senior Biostatistician Resume Examples & Samples

6 years of experience and a BS degree in Biostatistics or equivalent degree
2+ years of experience and an MS degree in Biostatistics or equivalent
1+ year of experience and a PhD degree in Biostatistics or equivalent
Industry experience in the statistical analysis of biomedical data using SAS® software is necessary

Senior Biostatistician Resume Examples & Samples

Involved in early development planning of development strategies to ensure that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs
Performs sample size estimation for clinical trials
Identifies appropriate statistical methodology needed to meet trial objectives
Participates in meetings to identify data collection instruments and database design requirements to ensure that the data evaluated are free of bias, contain maximum information, and satisfy analysis requirements
Contributes to decision making on design and data collection ensuring alignment with trial objectives
Analyzes data and interprets results for publications
Performs peer review of protocol, statistical analysis plan, trial report, and other major deliverables including publications
Prepares reports to effectively communicate results of clinical trials to the project team, senior management, regulatory agencies and/or individual investigators
Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, or investigators
Oversees statistics-related activities of CROs to ensure that timelines are followed
Conducts research on statistical methodology, pursues solutions to various technical problems, adapts known methods, and develops new methods
Keeps management Informed on important scientific/statistical issues that may arise, in a timely manner
A PhD (preferred) or a Master’s degree in Statistics / Biostatistics with knowledge of biomedical sciences
Minimum 7 yearsrelevant experience in a pharma or biotech environment at the PhD level; a minimum 10 years at the Master's level
Experience and knowledge in the design, statistical planning, data analysis, and reporting of clinical trials is also required
Hands-on knowledge of SAS is a must; R is optional
Knowledge of statistical regulatory requirements / regulations is a plus
Must have excellent communication skills (verbal and written), highly organized, and have strong attention to detail, clarity, accuracy and conciseness
Must be highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)
Ability to work in a team environment is critical
Must successfully exhibit Insmed’s five (5) core corporate competencies of: Excellence, Accountability, Driven, Collaborative and Solutions; along with any other position specific competencies

Principal Biostatistician Resume Examples & Samples

Provide broad statistical support, including trial design, protocol and CRF development on specific studies
Coordinate and lead a project team to successful completion of a project within given timelines and budget
Perform review of derived datasets, tables, figures and data listings
Contribute to the development and delivery of internal and external statistical training seminars and courses
Review position papers based on current good statistical practice
Well established global Early Phase Biostatistics department
Familiarity with regulatory/research guidelines on drug development, GCP, and statistical principles (especially ICH guidelines)
Ability to work on multiple projects, plan, organize and prioritize activities
Competent in written and oral English
PhD in Statistics or related discipline is preferred
Experience in Early Phase studies with good pharmacokinetic knowledge

Principal Biostatistician Resume Examples & Samples

Professional attitude and Attention to detail
Good business awareness/ business development
Experience with CDISC is a plus

Senior Biostatistician Resume Examples & Samples

Interact with clients with regard to data analysis, scope of work, and budget
Review derived datasets and all types of statistical analysis deliverables
Develop complex analysis strategies, and execute them using efficient programming techniques (software: SAS)
Training/mentoring of junior members of the department
Representing PAREXEL at client meetings
You have a thorough understanding of statistical issues in both clinical trials (and other randomized experiments) and observational studies (e.g. comparative cohort studies, case-control, retrospective/prospective cohort)
You will have experience in statistical analysis in a clinically related subject, either within clinical trials or in Epidemiology, either academically or professionally – and/or Outcomes research
Experience with oncology and/or diabetes trials would be an advantage
Good oral and written English communication skills are mandatory
Ability to travel as required

Senior Biostatistician Resume Examples & Samples

2+ years of industry oncology experience as a Biostatistician
Excellent working knowledge of SAS Language, SAS Procedures, and SAS Graphs
Statistical methodology knowledge: one and two sample t-test, categorical data analysis (Fisher’s Exact test, Chi-squared test), analysis of variance and covariance, logistic regression. In addition, excellent understanding of the handling and analysis of oncology data
Good analytical skills, ability to communicate effectively, professional attitude, self-motivated

Principal Biostatistician Resume Examples & Samples

Perform or supervise complex statistical analyses and create or provide input to statistical reports – usually in English
Cooperate with other biostatistical and company departments to optimize the global efficiency
Act as a pro-active advisor for all types of analysis during the proposal process as well as during the project life cycle; define strategies and evaluate the statistical resources needed to meet the defined goals
Coordinate Biostatistics related project activities for successful completion within given timelines and budget
Produce and provide expert input to analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents
Quality control of all kinds of statistical deliverables
Degree in Biostatistics/Statistics or relevant quantitative sciences degree and a Masters or PhD in a statistical subject
You are able to work independently and in a team
You are confident, self-reliant, and a quick learner
You have advanced SAS programming skills

Senior Biostatistician Resume Examples & Samples

Interact with clients as key contact with regard to statistical and contractual issues
Perform QC of derived datasets, tables, figures and data listings produced by other members of the department
Check own work in an ongoing way to ensure first-time quality
Provide a supporting role as a non-voting independent statistician providing data and analysis for DMC review
Good analytical skills and Good project management skills
Ability to work independently and Good mentoring/leadership skills and
Competent in written and oral English in addition to local language
Experience working in Industry – Biopharmaceutical or CRO required

Biostatistician Resume Examples & Samples

Good Project Management skills
A good understanding of statistical issues in clinical trials
Prior experience with SAS Programming required
Good mentoring / leadership skills

Senior Biostatistician Resume Examples & Samples

Good analytical skills
Professional attitude
Good mentoring/leadership skills
Competent in written and oral English in addition to Russian
1 to 3 years of experience working in a related discipline

Research Biostatistician Resume Examples & Samples

Collaborate with clinical and other investigators to develop meaningful questions that can be robustly tested to address a study’s aims
Doctorate in statistics, biostatistics, epidemiology, statistical genetics or related field and 1- 5 years of related experience
Experience in phase I-IV clinical trials and/or epidemiologic studies

Biostatistician, Master s Level Resume Examples & Samples

Collaborates and contributes to preparation, implementation, and review of clinical trials and other multisite studies
Sound understanding of regulatory guidelines in a clinical research setting
Master’s in biostatistics, statistics, mathematics, statistical genetics, or related field with at least 3 years of clinical trials experience or Bachelor’s degree with at least 6 years of clinical trials experience
Experience with statistical software packages such as SAS, R, PASS, NQuery, S-Plus, etc
Sound knowledge of theoretical and applied statistics.Effective skills in communication and team collaboration
Experience in Phase I-IV FDA-regulated trials (i.e., trials conducted under an IND or IDE)

Senior Biostatistician Resume Examples & Samples

Completing Statistical Programing and Simulations, Control Charting, Sample Size Calculations, Design of Experiments, Distribution and Outlier Analysis, Transformations, Statistical Hypothesis Testing, Regression and Anova, Multivariat Analysis, Descriptive Statistics
Statistical Software expertise
Candidate should be able to work independently within a highly regulated industry
Bachelor’s degree or equivalent and 7 + years of experience OR Master’s degree in statistics/biostatistics/mathematics and 4 + years of experience OR PhD in statistics/biostatistics OR PhD in related disciplines with M.S. in statistics/biostatistics and 2 years of experience. #LI-GZ
In-depth and broad understanding of a variety of statistical methodologies to form technical solutions
Demonstrated ability to guide the successful completion of projects and function in a project leadership role
Statistical programing capability (SAS)

Senior Biostatistician Resume Examples & Samples

Excellent knowledge in Statistical Theories and Methodologies as applied to Medical Sciences
Strong knowledge of SAS programming, good analytical skills, ability to communicate technical concepts clearly, concisely, and understandably to non-statistical colleagues
Sound understanding of regulatory guidelines in a pharmaceutical research setting
Thorough understanding of clinical trial documentation leading to good knowledge of the therapeutic area and complete understanding of the objectives of the protocol
Work to the specifications in an analysis plan, related SOPs, and guidelines
Keep informed of statistical techniques as applied to clinical trials and of new and updated SAS procedures for statistical analysis by reading relevant journals and attending courses/statistical meetings
Write statistical sections of final integrated reports that are accurate, clear, concise, thorough, and objective
Ensure the accuracy of statistics as well as their interpretation in final reports
This role will partner with Internal Shire clinical team, Medical Monitor, Biometrics team, Medical Affairs, Regulatory Affairs, Clinical Research Organizations (CRO)
Some domestic and international travel may be required

Senior Biostatistician Resume Examples & Samples

Provide statistical expertise into the development on clinical studies (design, sample size, modelling/simulations)
Provide statistical input for protocol writing and review of clinical study documents
Analyse clinical data and report statistical results
Collaborate with cross-functional internal resources (clinical data manager, clinical project manager, scientists, medical directors) on different health benefit areas
University degree (PhD/MSc) in Statistics or Mathematics
Comprehensive knowledge of biostatistics in all phases of clinical development, in particular in planning, execution, analysis and reporting of clinical studies
Minimum of 4 years’ experience in the field of clinical research
Strong analytic thought process and ability to interpret results
Ability to work on multiple assignments at the same time
Proficiency with various statistical methodologies applied in clinical trials and knowledge of regulatory guidance
Good communication and team-player mindset
Knowledge of adaptive design from theory to practice is a plus

Biostatistician Resume Examples & Samples

PhD with 2+ years or MS with 4+ years working experience working on clinical trials in the pharmaceutical industry, biotechnology industry, or academia
Thorough understanding of statistical principles with the ability to practice and implement them. Ability to provide solutions to a variety of technical problems of moderate scope and complexity and to perform complex statistical modelling and simulation
Proficiency and experience in SAS programming, and knowledge of SAS procedures and other statistical software. Ability to learn new statistical software as needed
Able to be flexible when priorities change. Able to deal with ambiguity
Knowledge of medical/biological terminology and clinical practice in hemophilia is preferred

Biostatistician Resume Examples & Samples

Consults with investigators to determine questions of interest and data needed to address those questions
Determines and carries out appropriate statistical analyses
Interprets and presents data descriptions and analysis results, including the explanation of statistical techniques used, the assumptions made and the generalization of results
Documents methods and results through preparation of reports
Writes statistical methods sections of manuscripts and abstracts for publications or presentations
Writes computer programs to analyze data using available statistical software
Advises users how to best utilize database information
Designs study and data collection instrumentation to best answer questions within given time and personnel constraints
Communicates with key entry staff for accurate entry of data
Edits, organizes and maintains computerized data files
Handles multiple simultaneous projects or multiple aspects of a large project
Demonstrated expertise in standard statistical software and database management packages is required
Individual must exhibit a high degree of motivation and work effectively within a group setting
Must be able to handle time management of multiple simultaneous projects

Senior Biostatistician Resume Examples & Samples

Oversee statistical aspects in the design and analysis of clinical trials, including project management, statistical analysis, report preparation, and advising other project statisticians
Function as Biostatistics Project Leader for multiple protocols, projects, or NDA projects, including coordinating with other PPD divisions and interacting with the client and regulatory agencies
MS/MA degree in statistics, biostatistics, mathematics or related field and a minimum of 4 years experience or
Ph. D. and a minimum of 2 years experience or
Equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills and abilities
Strong SAS programming skills
Ability to direct and promote teamwork in a multi-disciplinary team setting
Proven performance of required tasks, as evidenced in outstanding performance in current tasks and/or documented record of accomplishments
Demonstrated initiative and motivation
Work is performed in an office/ laboratory and/or a clinical environment
Exposure to biological fluids with potential exposure to infectious organisms
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists
Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs
Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences

Principal Biostatistician Resume Examples & Samples

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years’) or equivalent combination of education, training, & experience
Expert knowledge of the statistical principles underlying clinical trials
Expert statistical skills
Expert knowledge of the regulatory issues associated with the reporting of clinical data in the submission process
Expert consultative skills
SAS® programming skills and familiarity of other statistical packages (e.g. StatXact, Nquery) and understanding of database structures
Good organizational skills across multiple projects, managing own and team work loads
The ability to adapt and adjust to changing priorities
Ability to work in a multi-disciplinary team setting
Demonstrated initiative, motivation and problem solving skills
Positive attitude and the ability to organise a team and work well with others
Evidence of mentoring skills as shown by leadership of multiple projects and team members
Exposure to electrical office equipment
Ability to work in an upright and /or stationary position for 6-8 hours per day
Frequent mobility required

Senior Biostatistician Resume Examples & Samples

Coordinate the development of analysis plans, table shells, programming and table specifications, the production of tables, listings and figures, data review and statistical analysis
Manage customer relationships
Familiarity with other relevant statistical computing packages such as nQuery
Working knowledge of relevant Data Standards (such as CDISC/ADaM)

Senior Biostatistician Resume Examples & Samples

To institute and perform complex statistical techniques to review and analyse clinical data
To perform statistical analysis, then present and defend interpretation of study results through presentation of abstracts, papers and submission of publications; assure accuracy of summary tables, graphics and interpretation of statistical analyses used to support submissions, presentations and publications
For the statistical soundness and validity of study protocols, investigational plans and data collection instruments
For sample size estimation, randomisation schema, statistical analysis plans, and authoring of statistical sections in protocols for clinical studies
For development of data quality standards; develop programs that satisfy the standards where needed; and provide quality control for statistical programs and methodology
To communicate with regulators, consultants, physicians, and other internal and external sources as needed to support submissions, analyses, presentations and publications; interacts with regulatory reviewers to negotiate appropriate design and analysis methods; participates in investigator meetings to present methods and conclusions
To maintain awareness of current regulatory requirements, trends and philosophies related to statistical analysis of clinical study data
For the development and review of standard operating procedures for the analysis of clinical study data
To provide statistical support to Regulatory Affairs, Quality Assurance, product development, Scientific and Medical Affairs and other areas of the company as directed
Collaborate closely with Global Clinical Development personnel in the scheduling of statistical deliverables
Bachelor's degree or preferably an advanced degree (Masters) from an accredited institution in Statistics, Biostatistics, Mathematics with an inclination towards application of statistics/biostatistics for laboratory and clinical research
SAS Certification desired
Experience as a health sciences biostatistician in an industry or academic environment
Ability to handle multiple projects and demonstrates problem solving and judgement skills
Communication, team work and attention to detail
Knowledge of industry standards and best practices in data management and applicable country regulations (US FDA, ISO, ICH, CDISC)
Experience with Data Management Systems such as Oracle Clinical, Medidata, Inform or Datafax
Experience with Microsoft Access, Excel, Word, Powerpoint, Sharepoint, Visio and Project

Biostatistician Resume Examples & Samples

Assist with protocol development and protocol and case report form (CRF) review
Advise data management staff on database design and critical data. May advise on validation checks
Assist project lead in fulfilling project responsibilities
Understand the Scope of Work, budget and quote assumptions, estimate the work completed, and manage scope for single studies. May manage project budget and resource requirements and provide revenue and resource forecasts for single studies, under supervision
Provide guidance to lower level and/or new staff
Under supervision, act as statistical team lead
Familiarity with basic statistical methods that apply to applicable clinical trials
Basic knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Strong organizing skills
Aptitude for, and working knowledge of SAS computing package
Ability to accept direction of lead team members
Master's degree in biostatistics or related field; or equivalent combination of education, training and experience

Biostatistician Resume Examples & Samples

Possession of a Master's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) with laboratory courses in a related discipline, or six (6) years related experience in lieu of degree
No experience required beyond a Master’s degree
Knowledge in statistical methodology, software languages and computer systems
Ability to work on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors
Ability to develop and implement problem solving techniques
Ability to exercise judgment within defined procedures and policies in selecting methods, techniques and evaluation criteria for obtaining results
Strong communication skills with the ability to interact with people from diverse areas and disciplines
Knowledge of scientific terminology used in the biopharmaceutical/clinical environment
Detailed understanding of automatic data processing, Statistical Analysis System (SAS) or R
Working knowledge of general principles related to statistics and data management analysis
Experience working with high dimensional biomedical data (e.g., microarray, genomic, or immune assay data)

Biostatistician With Sas Programming Resume Examples & Samples

Draft or review protocol and statistical analysis plan for HEOR studies including real-world studies, post-hoc RCT analysis or indirect treatment comparison
Execute the analysis, interpret the findings and summarize the results, support internal communication and scientific publication
Prepare, verify, and manage research data sets from administrative health insurance claims, electronic medical record databases, randomized clinical trials, or other sources as per provided specifications
Develop SAS macro libraries to standardize routine analysis or implement new methods
Strong hands on experience with standard software package as SAS, knowledge of R, OpenBUGS, VBA or other analytic packages a plus
Self-motivated with ability to meet deadlines
Advanced degree in statistics, public health, epidemiology, psychometrics, or related quantitative sciences plus >4 years of experiences in statistical modeling

Senior Biostatistician Resume Examples & Samples

Perform duties of a Trial Statistician to support regular clinical trials within national or international development projects or for marketed products as required. Collaborate with Trial Clinical Monitor and trial teams incl. pharmacokineticist in planning clinical protocols conforming to company and regulatory agency guidelines
Support other Trial Statisticians in their responsibilities. Support Project Statisticians in their responsibilities, especially in their statistical responsibilities in the planning and preparation of regulatory submissions and contribute to efforts on cross-trial planning and harmonization
Plan valid, efficient and cost effective clinical trials, typically based on outlines provided by Project Statisticians. Prepare Statistical Methodology sections for the protocols and the Trial Statistical Analysis Plans (TSAPs). Support other Trial Statisticians in their responsibilities
Analyze data from phase I to IV trials incl. responsibility for program validation. Support other Trial Statisticians in their responsibilities
Prepare accurate, high quality reports of clinical trials for registration of drugs and biologics, and publications. Support other Trial Statisticians in their responsibilities. Support other Trial Statisticians in their responsibilities
Review and evaluate proposed case report forms for consistency with information needs for the protocol
Review randomization to be used in the clinical trials

Biostatistician Resume Examples & Samples

Advise on current and future digital studies, staying up-to-date with current advanced data analytics both in standard statistics and machine learning
Maintain efficient interfaces with internal QSI Biostatisticians and external clinical teams including global clinical statistics
Maintain records for projects and archive trail / project analysis and documentation which may involve designing or enhancing data storage system
Participate in the selection of CROs and supervise QSI project activities performed by CROs
Participate in or lead non-clinical activities
Help proof read statistical analysis plans (SAP), summary reports and presentations for accuracy and clarity
3+ years of relevant professional experience
Demonstrable expert knowledge of the R programming language and good programming practice (code annotation, version control, etc.)
Demonstrable leadership in driving scientific analytical plans and methods development
Demonstrable ability in driving effective communication with cross-functional scientific/clinical teams
Strong communications skills and used to representing the group you work in across a larger organisation and throughout the wider external community (in this case it will be the scientific community)
Used to successfully explaining complex ideas to non-experts
Proven organizational and project management skills

Senior Biostatistician Resume Examples & Samples

Consulting with clients on clinical trial design, clinical trial program design, statistical / regulatory issues adding value by proactively suggesting approved ways of working
Ensuring all work is processed on time to appropriate quality levels and within budget
Understanding the regulatory requirements related to specific therapeutic areas and the implications for the statistical processing and analysis
Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner
Providing broad statistical support, including trial design, protocol, and case report form development on specific studies
Providing technical advice and support to non-biostatisticians within the company.Undertake the full range of duties relevant to the leadership, management, and development of the team to ensure their performance meets and or exceeds both the business and their own personal goals/objectives. Maintain a positive, results orientated work environment, building partnerships and modeling
Preferably employed as a biostatistician in the pharmaceutical industry / CRO for 3 years or
5+ years general experience as a senior biostatistician
Working knowledge of Clinical Data Interchange Standards Consortium (CDISC)
Fluent in English (speak, read, write)

Senior Biostatistician Resume Examples & Samples

Performs statistical analysis for pre-clinical, clinical, and post-marketing projects in support of product development and U.S. and international product registrations
Responsible for statistical integrity and accuracy of clinical data prepared for regulatory filings
Provides statistical support consistent with prevailing standards for good statistical methodology, regulatory, and departmental guidelines and in compliance with associated ICH, US and EU regulations
M.S. or Ph.D. (preferred) degree in statistics, biostatistics, or closely related field
Minimum 4 years' experience in the pharmaceutical/biotechnology industry in support of clinical studies preferred
Good working knowledge of major statistical software packages (e.g., SAS, S-plus, R) is a plus
Excellent communication skills with the ability to interface at all levels, both within Cerus and with outside organizations
Ability to integrate statistical and biomedical concepts
Time management skills (timelines, schedules, task prioritization)

Senior Biostatistician Resume Examples & Samples

Coordinate the development of analysis plans, table shells, programming and table specifications, the production of
Familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials
Familiarity with other statistical computing packages such as S+, SUDAAN, StatXact

Biostatistician Resume Examples & Samples

Support Adaptive’s research and diagnostic product offerings by creating and maintaining excellent automated system for ongoing quality control as part of product development
Develop statistical data analysis approaches that help both clients and internal analysts make the most out of ImmunoSEQ and ClonoSEQ data
Support the development of new research and diagnostic assays by performing statistical analysis for analytical and clinical validation experiments
Maintain and establish good working relationships with internal and external scientists and business representatives

Senior Biostatistician Resume Examples & Samples

Participates as a highly valued member of core teams for Phase II and III stages, clinical sub-teams, and core teams
Acts as liaison on behalf of department with internal personnel and outside customer representatives at various levels concerning processes or scheduling of specific phases of projects or contracts
May supervise other Biostatistics staff
Ph.D. in Biostatistics and 6+ years of relevant work experience, or M.S. in Biostatistics and 9+ years of relevant work experience
Possesses an advanced understanding of modern drug discovery and development processes
Demonstrates advanced and inspiring intellectual and technical leadership

Biostatistician Resume Examples & Samples

Implement different statistical methods to identify significant associations, including both parametric and non-parametric methods (e.g. linear regression, robust linear regression, t-test, ANOVA, Kaplan–Meier log-rank test, Cox proportional hazards test, Mann–Whitney U test, Kolmogorov–Smirnov test)
Create scripts to parse data generated by high throughput sequencing experiments (e.g. RNA-seq, ChIP-seq, bisulfite sequencing)
Create and maintain simple databases for data management
Create graphs and data visualization strategies that enable better experiment interpretation
Assist researchers with power calculations and experiment design
Communicate results and assumptions of analyses in written and oral summaries

Biostatistician Resume Examples & Samples

Provides statistical analysis programming, including completion of basic descriptive and inferential analyses and the interpretation of results
Reviews data for discrepancies, interact with data managers, and create analysis datasets
Presents interim and final results, including tables and figures, and provide a written description of methods and statistical analyses used
Conforms to statistical programming and analysis standards
Must be able to perform the essential functions of the Biostatistician I
Employees in this position work on multiple tasks simultaneously and, as such, may have competing deadlines or time constraints, which may require consultation with their supervisor to prioritize responsibilities

Biostatistician Resume Examples & Samples

Proficient in Perl, Python, or other scripting languages for data munging
Skills in statistical estimation, statistical inference, and modeling fitting diagnostics
Proficient in R or SAS
Knowledge of non-parametric statistics, Bayesian methods, and small sample size methods
2 year of experience doing collaborative biostatistics
2 years of experience manipulating large databases programmatically
Previous experience in an academic institution, or academic hospital setting
Master's degree in biostatistics, statistics or related field
Ability to work independently and collaboratively
1 year of experience doing collaborative biostatistics

Biostatistician Resume Examples & Samples

Analyzes and interprets data from various sources in the pre-clinical and clinical development of recombinant vaccines
Designs studies for CIL independantly, related to pre-clinical and clinical development of recombinant vaccines
Compiles reports, charts and tables based on established statistical methods from data generated by the CIL
Master Schedule Coordinator and GLP Archivist for any GLP studies undertaken in the CIL
Bachelor’s degree in Statistics or Biology preferred, but not required
Experience with statistical analysis preferably but not necessarily in the biomedical field
Familiarity with standard concepts, practices, principles and procedures of statistics, with the ability to statistically analyze laboratory and epidemiological data, especially from data from clinical trials
Experience working in compliance , specifically with Good Clinical Practices (GCP) and Good Laboratory Practices (GLP)

Biostatistician Resume Examples & Samples

Assists in providing consultation to study investigators in the areas of protocol development, study design, analysis plan, sample size / power calculations, and interpretation of study data
Assists in the preparation and submission of grants, manuscripts, and presentations
Provides statistical analysis programming, including completion of descriptive and inferential analyses and the interpretation of results
In consultation with supervising or faculty statistician, seeks out opportunities to become involved in statistical leadership through teaching, supervision, mentoring, or developing own methodological research
Must be able to perform the essential functions of the Biostatistician I and II positions

Biostatistician Resume Examples & Samples

Must be self driven and able to communicate effectively with collaborators in medicine and biology
The position will require frequent interactions with others in all phases from experimental design to paper submission. As such, exceptional written and oral communication skills are required
Time management skills are necessary, as there will be multiple active projects at any given time. A successful candidate will manage his/her time and prioritize importance of various projects

Senior Biostatistician Resume Examples & Samples

Assist in selecting the optimal clinical trial design and selection of outcomes to maximize the chances of achieving the desired goalCalculate the sample size options, using the available assumptions
Collaborate on the protocol preparation with specific responsibility to prepare the appropriate statistical section, and assisting in the preparation of Case Report Forms with Clinical Data Management
Write and lead the implementation of the Statistical Analysis Plan (SAP) and randomization methodology specifications
Provide or review statistical results output and provide feedback to the clinical team on the meaningfulness of the results obtained
Write and review the statistical methodology sections(s) of study reports and integrated summary reports
Work closely with the clinical scientists and clinical operations members
Support the contracting and managing of statistical services from CROs, as needed, for project activity
Review and comment on regulatory documents, such as Clinical Study Reports, as well as publications and poster presentations of clinical results
Liaise with headquarters (Columbus, USA) statistical services colleagues for consultation and coordination

Biostatistician / Applied Mathematician Resume Examples & Samples

Advise on current and future digital studies, staying up-to-date with current advanced data analytics
Both in standard statistics and machine learning
Hands-on analysis of study data following internal project management guidelines
Maintain efficient interfaces with internal (QSI biostatisticians) and external clinical teams including the global clinical statistics team, data integration engineers and analysts
Participate in the selection of CROs, vendors and technologies, as required, and supervise QSI project activities performed by CRO
Program according to good coding practices and ensure internal quality control and reproducibility of deliverables
Maintain records for all assigned projects and archive trail / project analysis and associated documentation. May involve designing or enhancing data storage system
Train staff on trial and project level activities and internal processes
Good understanding of global clinical trial practices, procedures and methodologies
Good understanding of regulatory requirement relevant to Biomarker Development (e.g. GCP, ICH)
Demonstrable experience with any of the following: SAS, python, SQL, R
Experience in providing recommendations for maintenance or development of global policies, procedures and clinical data presentation standards
Good organizational, presentation and project management skills; ability to work under pressure and meet timelines
Strong interpersonal and communication skills; ability to work as part of an international team without close supervision

100

Distinguished Biostatistician, Oncology Resume Examples & Samples

Represent statistical expertise and institutional memory in clinical development in specific therapeutic areas to ensure that research programs and submissions are statistically rigorous and efficient
Communicate with external statistical experts and project and trial statisticians with respect to appropriate trial design, analytic techniques, rules for addressing statistical issues, analysis plans, and inferences from data
Review from a statistical viewpoint important protocols, clinical trial reports, regulatory submissions, and manuscripts for presentation or publication to ensure quality and consistency across projects and across trials within projects within the therapeutic areas of expertise
Represent BIPI as a statistical leader in a field of expertise at national/international conferences, meetings and organizations and chair sessions in international statistics meetings
Provide internal statistical review requested by Senior Management, e.g., in-depth evaluation for in-licensing potential of new drugs
Mentor statisticians on the technical track and train non statisticians (clinicians, e.g., via TMM and TCM training)
Serve on Data Monitoring Committees
Perform the responsibilities of a Senior Principal Statistician for a high profile project

101

Principal Biostatistician Resume Examples & Samples

MS with 10 or PhD with 8 years or more working on clinical trials
Past frequent interaction with FDA
BLA/NDA experience essential
EMEA/CPMP and preparation of an MAA an advantage

102

Principal Biostatistician Resume Examples & Samples

MS/MA degree in statistics, biostatistics, mathematics or related field
5 years experience required (including experience mentoring personnel and coordinating the work of project teams)
Must have experience serving as a lead biostatistician on multiple projects
Demonstrated ability to successfully lead the biostatistics elements of multiple clinical projects simultaneously
Or Equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills and abilities
Strong knowledge of statistical principles underlying clinical trials and strong statistical skills
SAS programming skills and familiarity of other statistical packages and understanding of database structures
Ability to adapt and adjust to changing priorities
Ability to interpret and contribute to company policies

103

Biostatistician Resume Examples & Samples

Work with the Director of Biostatistics on the management of various data bases
Organize the data management and analysis relative to specific statistical analysis plans
Coordinate data management and data analysis with partners
Create programs in SAS and/or R for the creation of analysis datasets
Follow all SOP in the management and development of datasets
Create programs in SAS and/or R for statistical analysis
Perform documentation of programs and datasets created
Production of deliverable that addresses the needs outlined by the researcher in the statistical analysis plan
Consult with PIs on developing appropriate statistical analysis plans
Develop and present research for meetings or conferences
Aid in the preparation of journal manuscripts and grant applications for peer review,
Learn and develop new statistical and programming skills as needed
Manage, track, and analyze data sets related to the evaluation of antibody responses to HIV-1 vaccines for human and preclinical studies
Work together with the binding antibody laboratory PI, DHVI statistical core and laboratory staff to manage, track and quality control datasets. Interact with scientists performing the assays and the DHVI statistical core to further develop processes and tools for optimal data analysis of large high content data sets
Oversee the use of the custom tools. Interact as primary liaison with lab data operations and statistical teams of an off-site collaborator (daily) to resolve data uploads, corrections/modifications and QCs. Evaluate system problems, develop and implement corrective action plans
Develop and implement systems for data quality control. Implement performance metrics for measuring workflow efficiency and generate work flow analysis on a per-study and per-technician basis. Create binding antibody data sets from these data in conjunction with the appropriate oversight groups (e.g., the Quality Assurance Unit) to maintain Good (Clinical) Laboratory Practices
Maintain and query databases of binding antibody data including all quality control parameters (including Levey-Jennings tracking, preset positivity criteria, and validation data). Assist with the implementation of new data queries as requested
Collaborate with the DHVI statistical programming unit to analyze large data sets. Provide feedback to the statistical programming unit and to the investigators or program management as appropriate to refine queries and analyses, developing reports on new data queries as appropriate
Provide data summary and analysis reports including both data and text summaries. Work with the DHVI statistical core to mine clinical information databases
Initial laboratory training will be provided on scientific laboratory methods for the evaluation of antibody responses for educational purposes to provide an overview of the work
Work with the laboratory PI, statistical team and laboratory staff to perform additional duties as needed for the completion and evaluation of antibody responses
Perform any other data management or statistical tasks deemed necessary by the Director for completion of projects

104

Principal Biostatistician Resume Examples & Samples

Provide broad statistical support, including trial design, protocol and CRF development on
Familiarity with regulatory/research guidelines on drug development, GCP, and statistical
PhD in Statistics or related discipline with 3+year experience or MS in Statistics or related

105

Biostatistician Resume Examples & Samples

Assist the Chief of Biostatistics in providing statistical regulatory oversight support and technical assistance to the Tech Based Programs and advance development vaccine/drug/device programs of MRMC
Adhere to Biostatistics SOPs and internal procedures, FDA Guidance’s, ICH documents, and if applicable, the external regulatory sponsor’s SOPs/ SSPs
Attend IPT and working group meetings (either on-site or via TCON, in support of the Chief of Biostatistics
Provide advice and consultation support to the IPT and working groups, and communicate with the Chief of Biostatistics in regards to key issues that arise
Assist the Tech Based Programs and advance development vaccine/drug/device programs with the development of the position papers, statistical analysis plans, the mock tables, listings, and figures, the interim analysis plans, statistical programming validation plans, technical issues associated with DSMB reports, technical issues associated with data analysis, and technical issues associated with FDA data deliverables
Assist medical writers with statistical issues associated with preparation of the Clinical Study Report and other documents to be submitted to the FDA
Assist the Tech Based Programs and advance development vaccine/drug/device programs with the statistical analyses for the FDA Annual Report and assist the USAMMDA medical writers with statistical issues associated with preparation of the FDA Annual Report
Assist regulatory scientists and the medical writers with statistical issues associated with FDA communications and FDA briefing documents
Attend FDA meetings and conference calls
Assist the Chief of Biostatistics with other bio statistical tasks as requested
Possess a Masters or PhD in statistics or a related field and have at least 7-10 years of regulated non-clinical/clinical statistics experience. Extensive experience with FDA statistical deliverables is required
Must have experience working in teams and have a comprehensive understanding of medical product development and knowledge of FDA/ICH design and analysis standards and FDA statistical regulatory requirements
Provides biostatistics support off-site but shall be available to attend meetings in person at Fort Detrick, Walter Reed Army Institute of Research (WRAIR) or other Tech Based facilities. Meetings may be attended via teleconference unless on-site attendance is required by USAMMDA, WRAIR or other Tech Based facilities.Travel is not expected to exceed one trip (on average) to Fort Detrick, WRAIR, or other Tech Based facilities per week
Requires the ability to obtain a secret clearance

106

Associate Principal Biostatistician Resume Examples & Samples

Leading statistical analyses to support scientific and medical publications, as well as public presentations, in collaboration with a global publication team including external scientific leaders, clinicians, medical writers, and marketing representatives
Providing expert input into clinical trial data interpretation and presentation which may include data from oncology trials with novel designs
Providing technical direction to statistical programming in analyzing clinical trial data, and coordinating the statistical activities for publications
Solid knowledge of statistical analysis methodologies and clinical trial designs
Strong presentation and written communication skills. Able to function effectively in a team environment
An understanding of biology of disease and drug discovery and development in a variety of therapeutic areas

107

Biostatistician Resume Examples & Samples

Provide analysis of high-dimensional genomic and clinical data sets,including clinical survey data, pedigree data, (RNA) sequencing data, microarray data, proteomics data, multiplex PCR data or other complex #omic #data sets
Commonly performed analyses include hypothesis testing, data normalization, clustering, testing for differential expression, principal components analysis, generalized linear model development, feature and model selection, and functional enrichment and pathway analyses
Apply state-of-the-art and classical statistical approaches to a variety of clinical data sets to elucidate novel biological information and clinical relevance
The specific clinical areas of interest include family health history and inherited disease risk, infectious disease, biopolymer exposures, cardiovascular events, and pharmacogenomics, with continued expansion to other clinical fields
Independently prepare statistical analysis plans and generate descriptive and basic test statistics,perform basic analysis requests and generate intermediate statistical modeling results
Creates timelines for statistical project management, with assistance from project leader and statistical managers
Effectively work in a highly collaborative work environment,interacting with physicians, biologists,and quantitative scientists
Efficiently support, refinement and interpretation of analytical results from biological and clinical studies and activities destined for publication
Present at relevant scientific meetings or conferences
Document analyses, creates summaries, and presents results in written and verbal form to requestors
Able to work on any phase of a manuscript project, from initial meeting with an investigator to final review of a manuscript prior to submission for publication, with guidance
Builds documentation and organizational skills to effectively return to a project after long intervals during which no progress was made by other members of the project team
Contributes meaningfully to discussions of analyses and identifies next steps for analyses
Designs analysis data set specifications through writing own R and/or Python code, finds and corrects errors, and validates output and results
Combines multiple disparate raw databases and derives analysis variables accurately
Collaborates effectively with statistical programmers for supported projects
Identifies potential data problems from analytic queries and brings them to the attention of the team
Demonstrates understanding of project data collection processes and data sets and shares knowledge with collaborators
Also provide consultation or assistance when needed
Represents the functional group in project team meetings and contributes constructively to project discussions
Drafts statistical sections for study protocols, with guidance of senior or faculty statistician
Generates project randomization sequences
Provides input regarding data collection tools and data correction criteria and procedures
Understands study data and the intricacies of the process through which it is being collected
Handles and secures highly confidential and sensitive analyses and documentation
Collaborates closely with investigators, sponsors, and other project leadership to ensure that project results and conclusions are presented accurately and without bias
Participates actively in the statistical team responsible for designing and validating analysis data sets, programs, and statistical output products (tables, listings,figures)
Adheres to standard operating procedures (SOPs) of the center as they apply to documentation and validation of clinical research statistics
Develops leadership and communication skills and shares them with others
Manages project responsibilities with decreasing levels of supervision or regular support and takes initiative to complete project-specific responsibilities with minimal supervision
Demonstrates progress inability to multi-task

108

Biostatistician Resume Examples & Samples

Lead production and quality control of randomizations, analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents
Prior experience with SAS programming required
Good business awareness/ business development skills
Willingness to work in a matrix environment and to value the importance of teamwork
PhD in Statistics or related discipline with 1+year experience or MS in Statistics or related discipline with 3+ years of experience

109

Biostatistician Resume Examples & Samples

Leading a project team. This involves conducting team meetings, maintaining project timelines, assessing resources needed, providing resources, and preparing the budget. Ensure that Standard Operating Procedures are being followed and that appropriate project documentation is ongoing
Coordinate with programmers and data management personnel as to database maintenance, updating and documentation. Provide guidance for database structures for analysis
Create or provide specifications for analysis databases based on Data Management database
Provide sample size calculations and review protocols for completeness, appropriateness of clinical design, and sound statistical analysis
Provide randomization schemes and appropriate documentation
Develop statistical analysis plan, including table and listing specifications, and guide others on the team in its implementation
Program/validate statistical tables with an emphasis on efficacy endpoints. Provide proper documentation and oversee the work of others who assist in programming/validating
Prepare and review reports. Contribute to the statistical methods section and verify for completeness and consistency for reports
Interact with the sponsor on all aspects of the project
Understand project budget as it relates to project workscope and communicate proactively with management concerning potential changes in workscope
MS/MA degree in statistics, biostatistics, mathematics or related field and
Minimum two years experience required
Or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills and abilities

110

Biostatistician With Sas Programming Resume Examples & Samples

Develop statistical analytic plans, statistical expertise and data management techniques and skills
Manage real world database operations, analytic programming and statistical modeling activities
Assist project lead or departmental principals in study design, power calculation, CRF construction, analytic operations and reporting for retrospective and prospective studies
Assist project lead or departmental principals in analytic/computing resource planning,, work flow management and prioritization, and related logistic coordination
Prepare communication materials on analytic projects including processes, data, analytic findings for internal and external functional groups within or outside of CMS
Prepare slide decks for congress or manuscript submissions or internal or external communications
Plan and initiate analytic projects using the real world databases or clinical trial data warehouse in support of the CMS initiatives
Provides consultation for all CMS groups on research methodology and statistical or analytic issues
Vendor Management
Database licensing and maintenance
Analytic process formulation and standardization
Potentially supervising team of analytic and programming support

111

Senior Biostatistician Resume Examples & Samples

To perform duties of a Trial Statistician to support clinical trials within national, regional or international development projects or for marketed products as required. To collaborate with trial team members including Trial Clinical Monitor, pharmacokineticist, etc, in planning clinical protocols conforming to company and regulatory agency guidelines
To support Project Statisticians in their responsibilities, especially in the planning and preparation of regulatory submissions and contributing to efforts on cross-trial planning and harmonization
To plan valid, efficient and cost effective clinical trials under Project Statisticians’ guidance and to author Statistical Methodology sections for the protocols and the Trial Statistical Analysis Plans (TSAPs); To prepare accurate, high quality reports of clinical trials for registration of drugs and biologics, and publications; To prepare specifications for data analyses by CROs as required. To assure CROs’ compliance with BI SOPs
To contribute to the development of case report forms and to review for consistency with information needs for the protocol; To support management in resource planning and tracking for assigned trials

112

Biostatistician, School of Public Health R Resume Examples & Samples

Familiarity with SAS and R to manage and analyze data
Ability to create interactive web applications
Ability to write comprehensive technical reports and scholarly articles
Excellent organizational and interpersonal skills
Demonstrated ability to work effectively with faculty, students, and others

113

Biostatistician w / SAS Programming Resume Examples & Samples

Draft or review protocol and statistical analysis plan for HEOR studies including post-hoc RCT analysis, network meta-analysis or indirect treatment comparison
Prepare, verify, and manage research data sets as per provided specifications
Conduct analytic quality assurance procedures and ensure quality of final deliveries
Solid background on statistical modeling methods and simulation
Experience with conducting HEOR or RCT studies
Ability to work independently under general guidance
Strong hands on experience with standard software package as SAS, knowledge of R, OpenBUGS, or other analytic packages a plus

114

Biostatistician Resume Examples & Samples

Leading statistical aspects of regulatory submissions from design of clinical studies to analysis and reporting of results for all types of global regulatory submissions including 510(k)s and PMAs, and also post-market clinical follow up
To ensure that all clinical development efforts are conducted with appropriate statistical planning, maintains systems to monitor and maintain data and analytic integrity, and provides statistical interpretation of study results as per committed project time lines
Provide leadership in establishing and maintaining policies, standards, and guidance’s for biostatistics and data management operation
Responsible for providing appropriate statistical and data management resources for the strategy and design of clinical development plans. The position supervises both in-house and CRO activities related to data capture and management, statistical programming, and application of statistics to clinical trials data
Represent Philips in meetings with regulatory agencies and prepare oral/written responses to statistical questions raised by regulatory agencies
Interpretation of data and reporting, including clinical study reports and co-authoring manuscripts t in drafting peer-reviewed journal articles
We are looking for
5+ years’ experience in a statistics role with a strong preference for medical device industry, and in particular, in vitro diagnostics expertise
Expert knowledge of statistical methodology, applied statistics for the purposes of regulatory submission, claims substantiation and peer-reviewed publications
Reads, understands, and articulates interpretation of results
In depth understanding of regulatory requirements (FDA, PMA, ICH, GCP, etc) for optimal pathway to product approval, and how statistics can shape and accelerate the process
Able to write code for simple analyses and to use SAS at the expert level, knowledge of R is appreciated
Ability to apply statistical techniques most well-suited for specific requests in a manner that ensures accurate and robust conclusions
Open, clear and responsive in spoken and written communication
Commitment to deadlines
Expert knowledge of clinical data presentation standards
Team player, willing to provide help where necessary
Creative thinking (“out of the box”) to come up with different statistical alternatives to reach the project goal
Provide review and critical feedback of interpretation of results from other statisticians

115

Biostatistician Resume Examples & Samples

Utilize research methodology and data collection tools to ensure that appropriate data are gathered
Assist in planning statistical study design for planned projects
Conduct data analyses including but not limited to descriptive statistics, factor analyses, generalized linear models, random effects models, analysis of survey data, and other statistical methods
Manipulate and extract data from appropriate sources, including Emerging Infections Program databases in .NET, Access and Excel, and the National Healthcare Safety Network, for analysis using SAS
Prepare preliminary interpretations of analyses for sharing with scientific and public audiences, project teams, and/or department management
Prepare reports in accordance with the analytical results, including providing support for the development of manuscripts
Use data and other information related to performance and evaluation for the dissemination of scientific information related to healthcare associated infections and other program data in the form of presentations, reports, slides, and other materials (e.g. newsletters, federal documents)
Master’s degree in Biostatistics, Statistics or related field with a minimum of 4 year of experience
5 years of experience with quantitative analysis and data interpretation
3 years of experience with advanced statistical analysis and programming tools such as SAS, STATA, SPSS, or R
3 years of experience with SQL Server and writing SQL queries
2 years of Public Health experience
Work experience in analysis with generalized linear models including longitudinal data analysis, random effects models, and survey statistics
Demonstrated willingness and ability to continue to learn and apply new statistical methodologies for data analyses over time
Proficiency with MS Excel, Access
PhD in Biostatistics
2 years of experience working with the Centers for Disease Control

116

Biostatistician Resume Examples & Samples

Creates analysis datasets and associated dataset specifications; reviews data for discrepancies and works with the study team to resolve discrepancies
Prepares and presents interim and final study results (e.g., tables, figures and reports), interprets results, and describes the statistical analysis methods used
Works collaboratively with study team to support project needs and provide statistical perspective during all project stages (planning, enrollment, and post enrollment). This includes reviewing study materials prepared by other team members
With direction from supervising statistician, coordinates study statistical team to support project needs. This includes completing quality assurance procedures, ensuring statistical documentation is current, and archiving materials for completed deliverables
In consultation with supervising statistician, successfully negotiates timelines and manages competing deadlines
Recognizes potential areas of concern related to study design, statistical, or data issues. Works to understand issues, identifies potential solutions, and consults with supervising or faculty statistician
Actively expands own knowledge and understanding of statistical methods and programming
Conforms to statistical and shared data coordinating center working guidelines and standard operating procedures
With direction from supervising or faculty statistician, assists in the preparation of abstracts, presentations and manuscripts; includes drafting analysis plans
With direction from supervising or faculty statistician, communicates with study investigators and other clinicians regarding statistical issues, analysis planning, study results, and the interpretation of study results

117

Biostatistician w / SAS Programming Resume Examples & Samples

Should have very good writing, communication and programming skills, especially SAS
Good knowledge in R is a plus, but not necessary
Biostatistician with at least 2 years of experience supporting Phase 2/3 trials

118

Biostatistician w / SAS Programming Resume Examples & Samples

Previous experience in oncology is required
Master degree or higher in statistics or related field
Efficacious SAS programming skills

119

Principal Biostatistician Resume Examples & Samples

Serves as advisor, hands-on statistician and mentor on the strengths, opportunities and limitations of study designs and both innovative state-of-the-art and standard statistical methods
Participates as the statistical expert on cross-functional teams, to ensure that planned studies and experiments are statistically rigorous and efficiently designed and analyzed
Skilled at working with large data sets with expertise in large-scale inference, resampling methods, model development and assessment
Must have proven expertise with applying appropriate statistical methodologies in the following
First rate interpersonal and communication skills are essential with fellow team members, management and customers who have varied levels of technical or statistical background
Ability to prioritize and deliver to results with a high emphasis on quality
Ability to work collaboratively and effectively as part of multidisciplinary teams
Familiarity or experience in environments regulated under FDA or ISO
Demonstrated desire to mentor and develop others

120

Senior Biostatistician Resume Examples & Samples

A PhD degree in statistics or biostatistics with 2-4 years experience in pharmaceutical industry
Knowledge in Bayesian analysis, adaptive designs, and/or biomarker analysis is desired
In depth understanding of statistical concepts and techniques, ability to formulate real-world problems in a statistical framework and develop proper and efficient statistical methods, procedures, or innovative approaches for problem-solving
Good communication and interpersonal skills, highly self-motivated, ability to successfully conduct multi-tasks, ability to work independently with minimal supervision, pay attention to details and ability to work well in a team environment

121

Principal Biostatistician Resume Examples & Samples

Leads or assists in the development of design validation plans, study protocols, and statistical analysis plans in collaboration with members of the study team for the assigned projects
Performs statistical analysis and creates statistical reports including tables and listings for study reports and manuscripts
Collaborates with the data management group on developing data collection and analysis strategies
Assist in communicating study results in regulatory submissions, respond to regulatory queries and interact with regulators
Provides technical expertise and functional support to Clinical Study teams and other Business areas, such as Life Cycle Teams, Regulatory Affairs
Participates in various project teams as an advisor/SME ensuring proper use of statistical methodology & interpretation of clinical results
Provides mentoring, coaching, training and/or guidance as required
Responsible for maintaining and continuously improving the quality system and achieving quality objectives through daily actions

122

Senior Biostatistician Resume Examples & Samples

A PhD in Statistics or related field is required
Excellent analytical skills and knowledge of statistical methodology including experience with modeling and simulations are required
Proficiency with statistical software such as SAS, R or SPlus is required
Excellent verbal and written communication skills, including presentation skills, are required
Up to 10% travel is required.Biostatistics

123

Principal Biostatistician, Work From Home Resume Examples & Samples

Strong hands-on experience and knowledge with SAS and other statistical software
Strong knowledge in statistics including study design methodologies, categorical data analysis,
Excellent teamwork skills placing emphasis on supporting the goals of the group
Excellent verbal and written communication skills including presentation skills
Ability to work with within deadlines and according to procedures and rules
Ability to manage multiple protocols and participate in multiple clinical project teams
At least 6+ years of biostatistics in a regulated clinical research environment (pharmaceutical /
7+ yrs.experience in the following
Experience in oncology highly desirable
International experience and cross-cultural awareness preferable
Experience in interactions/meetings and/or submissions with regulatory authorities (eg FDA,

124

Senior Biostatistician Resume Examples & Samples

Principal Responsibilities and Duties
Develop statistical sections of protocols, assist in CRF creation/validation, generate randomization codes, develop statistical analysis plans, monitor data from on-going clinical trials, author statistical reports (75% of time)
Provide guidance to SAS programmers and other statisticians (15% of time)
Represent Biometrics department in interaction with regulatory agencies and health authorities (5% of time)
Support projects not based on currently running clinical trials (5% of time)
Job Specifications
Education and/or Experience
Supplemental Data

125

Senior Biostatistician Resume Examples & Samples

Ph.D. in Biostatistics, Statistics, or related field
Capable of functioning independently and collaboratively at an advanced level under the overall direction of the QSU Director
Experience with multiple statistical programming languages such as SAS and R
Outstanding oral and written communication skills with the ability to communicate technical information to all audiences
Skilled in descriptive analysis, modeling of data, and graphic interfaces
Demonstrated expertise in statistical methodology
At least two years of experience collaborating as a biostatistician is desirable
Certification in SAS
Experience supervising technical staff including training, mentoring and coaching
Experience developing and writing grant proposals

126

Biostatistician Resume Examples & Samples

MA/MS in Biostatistics, Statistics, or a closely related field required
Working experience and/or education in statistical analysis or clinical or biological data, including failure time and categorical data, required
Experience with statistical software required
Two-year MA/MS program preferred
Prior experience with MS Office (Word, Excel, Powerpoint) preferred
Experience with SAS is preferred, but a strong background in other relevant packages (e.g., STATA, S-PLUS or R) will also be considered
Proven, strong written and verbal communication skills, as well as experience working within a collaborative research team preferred

127

Principal Biostatistician Resume Examples & Samples

Serves as the statistical expert on cross-functional teams, working throughout assay/product development life cycles and in support of commercial laboratory operations
Selects and applies appropriate statistical methodology and techniques for obtaining solutions to all project related studies under general strategic guidance and in compliance with best practices
Must have proven expertise with applying appropriate statistical methodologies in several of the following
Variance component estimation
First rate interpersonal and communication skills are essential with fellow team members, management and customers who will have varied levels of technical or statistical background
Experience with Bioinformatics methods, tools and databases for NGS a plus

128

Senior Biostatistician Resume Examples & Samples

Primarily responsible for development of Statistical Analysis Plans (SAPs), mock shells, ISS/ISEs, and review of statistical deliverables
Collaborate with sponsors and investigators in DMCs/DSMBs
Participate in the review of clinical protocols and case report forms including preparation of statistical sections, sample size calculations, randomization, and potential interim analyses
Represent clients in interactions with regulatory authorities
Interact with clients across multiple therapeutic areas
Contribute to Business Development activities, e.g. proposals and client presentations
Provide statistical learning to co-workers and clients via seminars and/or webinars
Actively participate and support the efforts to grow the clinical statistics business unit
Masters degree in Statistics, Biostatistics, or related field
Strong medical statistics background
Minimum 4 years experience in the pharmaceutical industry
2+ years’ experience writing SAPs and working closely with teams preparing Tables, Listings, Figures and CSRs
Knowledge of ICH and FDA Guidances
Great communication/presentation skills
Attention to detail, ability to multi-task
Ability to provide insight into the current methods being used for clinical trials

129

Biostatistician Resume Examples & Samples

Provide statistical collaboration and/or consultation to research scientists, investigators, database designers, and managers of WRAIR/NMRC and outside clients. This includes communicating effectively in order to understand and clarify the goals of the client, and providing well-reasoned solutions to the problems presented by the client
Provide technical assistance to the staff, including assisting staff statisticians with design or analysis tasks and/or jointly meeting with clients seeking statistical and computing services
Assist in the development of formal experimental protocols subject to the Army, Navy, and Animal Welfare Regulations. Quoting from AR 40-33, "A person knowledgeable in biostatistics is required to review all proposals to ensure that the number of animals used is appropriate to obtain sufficient data and/or is not excessive, and the statistical design is appropriate for the intent of the study"
Assist in the development of the statistical portion of human protocols. Contractor shall provide expert consultation in the development of a statistical analysis plan (SAP) to meet the objectives of the protocol
Apply a variety of biostatistical methods and tools. Expected application areas include analysis of variance, survival analysis, logistic regression , generalized linear mixed-effects models and construction of graphical displays for statistical visualization
Perform SAS programming to meet the needs of clinical trials as defined in the SAP. Contractor will develop data display shells and mock tables, listings and figures to test the system prior to implementation. Contractor shall prepare and present final tables, listing and figures to investigators. Contractor shall maintain records and version control for program
Provide clear oral or written advice with regard to statistical procedures
Provide hands-on training on how to use statistical software's for all or some of the following: · SAS, PASS, SPSS or other statistical software packages. Web-based sites offering statistical tools for the purposes of design and analysis may be also available
Provide clearly written technical edits that improve statistical aspects of documents, such as research protocols or manuscripts from clients of the Department
Draft clearly written data, statistical design, sample size, and analysis sections for documents such as research protocols or manuscripts from clients
Co-author scientific/technical manuscripts
May assist in the development, analysis, or review of formal protocols subject to national and international regulations
Document critical reviews at an appropriate level for the intended audience. Reviews are conducted for manuscripts and publications written by others with regard to good statistical practices
With the approval of the COR, the employee may be given time and encouraged to review relevant statistical literature and adapt statistical methods as necessary
Shall internally document assumptions, data sources, databases, procedures, statistical analyses, and computer programming code so that results can be replicated even if the originating staff member is no longer available. Data sets, analysis software, and documentation shall be in digital format, accessible to the COR, and shall be provided to the COR upon expiration of the contract
Status report meeting with COR will occur on a weekly basis with Tuesday as the targeted day. Technical support meetings with the department staff and approved consulting and/or collaborative research with WRAIR/NMRC investigators shall be scheduled consistent with their needs
Products provided to the customers shall be free of obvious errors and consistent with statistical methods published in peer reviewed literatures. In all cases, reports, statistical algorithms, computer programs and data used to generate results shall be provided in digital formats
Shall provide weekly status reports delivered to the COR by COB on the last day of the month including the following: Topic of the task worked during that week, Name and Division/Directorate of the client, Date the task was requested by the client, Requested products , Type of animal species involved, whether a product was delivered, and the nature of any product delivered (meeting, e-mail, report, ..., etc.). In addition to the status report additional reports may be requested as deemed necessary by the COR
Masters’ degree in Biostatistics
Required Knowledge, Skills and Abilities: knowledge of applicable highly complex office procedures and techniques relating to position

130

Biostatistician Resume Examples & Samples

MSc+5 yrs experience or PhD+3 yrs experience
SAS programming skills and familiarity of other statistical packages (e.g. StatXact, Nquery) and understanding of database structures
Serve as lead statistician on selected multiple projects

131

Senior Biostatistician Resume Examples & Samples

Become familiar with the activities outlined in the department’s Working Practice Documents and contribute changes as needed. Learn and follow departmental procedures for statistical analyses and programming work
Serve as a lead statistician on large and complex projects
Lead a project team. This involves conducting team meetings, maintaining project timelines, assessing resource needs, providing resources, and budget preparation. Ensure that SOPs are being followed and that appropriate project documentation is ongoing.Provide sample size calculations and review protocols for completeness, appropriateness of clinical design, and sound statistical analysis. Also contribute to writing appropriate protocol sections
Provide randomization schemes and appropriate documentation. Provide specifications for analysis database, oversee its development, and assure completeness for use in all programming. Coordinate with programmers and data management personnel as to database maintenance, updating, and documentation
Write / review analysis plans and guide others on the team in its implementation. Define appropriate methods and procedures for statistical analysis. Develop or supervise creation of table and listing specifications. Develop or supervise creation of table and listing specifications. Ensure that proper validation for statistical tables and listings is being implemented
Perform statistical analysis for key efficacy endpoints
Prepare reports, manuscripts, and other documents. Contribute statistical methods section for Integrated Clinical and Statistical Report, Integrated Summaries of Safety, Integrated Summaries of Efficacy, and other documents
Interact with the sponsor on all aspects of the project and present to sponsor and regulatory agencies as needed
Communicate with sponsors concerning project workscope and budgetary changes after reviewing with management
Providing administrative support
Mentor other members of the department by providing project guidance and statistical advice and by promoting employee development, completing performance planning, and providing resource planning
Act as the representative of the department to other divisions
Provide general infrastructure support to the Biostatistics Department. Examples could include presentation / teaching at the Bios Department meetings, contributing to other general department documents or policies, assisting with Bios newsletter, helping in Bios department libraries, or training of new hires
Provide input to the Directors, Associate Directors, and Managers as to hiring recommendations, department policies, and resourcing requirement.Assist in bidding and business development activities. . Consult with business development with respect to bids and timelines
PhD degree is desirable

132

Biostatistician Resume Examples & Samples

Minimum 2 years experience or Master Degree
Basic knowledge of statistical principles applied to the design and analysis of clinical trials
Excellent problem solving skills
Evidence of supervisory/mentoring skills as shown by leadership of projects and team members

133

Clinical Biostatistician Resume Examples & Samples

Support and assistance in preparation of Statistical Analysis Plans for clinical trials
Design tables, listings and figures for statistical reporting
Develop, test, maintain, and archive SAS program code to perform statistical analysis and generate analysis datasets and statistical reports of clinical data
Perform statistical QC review of source code and output developed by other staff biostatisticians for statistical reports
Perform statistical review of clinical data and communicate data issues to data management and clinical staff
Design and prepare randomization schedules for clinical trials
Maintain tracking sheets and other documentation
Prepare Blind Data Review documents for clinical trials, including notes for special data handling and assignment of analysis populations
Miscellaneous duties, as necessary, in support of Clinical Biostats and Programming initiatives and business priorities and objectives
Minimum of a Masters Degree in statistics or equivalent academic credential; health sciences field preferred
Ideal candidate will have at least 2 years experience in the CRO and/or pharmaceutical industry. Understanding of the FDA, ICH, CDISC, and other applicable Guidelines related to the conduct of compliant clinical trials
Good understanding of basic statistical procedures and statistical methodology
Experience in SAS programming, including understanding of macros
Excellent organizational skills, written and verbal communication skills, and working knowledge of Microsoft Office Suite is a must

134

Senior Biostatistician Resume Examples & Samples

Collaborates with program staff on the implementation and analysis of statistical aspects of research protocols
Provides statistical consultation for clinical programs, including but not limited to protocol development, randomization, sample size assessments, efficacy evaluations, and data review
Provides input to project timelines, and ensures that project timelines for biostatistics deliverables are met for both internal and external clients
Ensures that project tasks are completed with acceptable quality for both internal and external clients
Coordinates with SAS programming staff to ensure the accurate programming of SAS clinical data extracts and data displays
Develops statistical analysis summary and analysis plans, including textual description of planned analysis and mock-ups of data displays
Reviews and provides comments on statistical summaries and analysis plans
Develops programming specifications to summarize the results of clinical trials, including analysis datasets and tables/listings/figures
Performs statistical analyses, including hypothesis testing and modeling
Provides tabular and written summaries of analyses and statistical methodology for Clinical Study Reports
Consults with sponsors regarding development of statistical analysis plans, protocol content and study design as dictated by the specific nature of the project
Interacts with Medical Writers to ensure appropriateness of data inferences
Writes pertinent sections of a clinical study report
Interfaces with clients and/or regulatory agencies as the project biostatistician
Attends team meetings and represent departmental needs for assigned projects
Understanding of GCP, ICH, and FDA guidelines and regulations applicable to conduct clinical research
Experience with, and mastery of, statistical methods commonly used in the analysis of data obtained from Phase I – IV clinical trials
Experience with SAS Base and SAS Stat, as well as strong data step skills
Ability to work creatively and independently to carry out assignments of a complex nature

135

Biostatistician Resume Examples & Samples

Content expertise in any of the following areas of health care: hospital care, primary care, cancer care, or palliative care
Health services research experience
Familiarity with either medical data or claims data
Two years of post-Master’s experience

136

Principal Biostatistician Resume Examples & Samples

Serves as statistical expert in the therapeutic area, key indication or compound under their purview and provides strategic input to the target patient value profile, clinical development plan, regulatory submission plan and the life cycle of a development compound, by suggesting innovative statistical methods that will help accelerate the development process or market access
For the therapy area and/or indication, coordinates the work of the biostatistician study lead, other biostatisticians and statistical programmers assigned to the Mission, to ensure high quality of statistical deliverables in close collaboration with external vendor partners
Act as the biostatistics lead for scientific evaluation of in-licensing opportunities
Acts as a technical resource for less experienced biostatisticians
Adheres to the company SOPs and processes
Frames questions and problems to incorporate multiple perspectives and provide a path to making sound decisions
Communicates complex issues in nontechnical language by using visuals, simulations and other illustrative techniques
Uses technical expertise to pro-actively influence business decisions
Identify and facilitate risk-mitigation combining quantitative sciences and disease area/competitive landscape knowledge
Such other responsibilities and projects that the Company may assign
Develops, maintains and ensures standardization across the clinical studies within the clinical program. Adheres to the GSS global standards
Manages and coordinates the biostatistical deliverables required for the NDA/MAA submission for the clinical program and ensures the deliverables are completed accurately and in accordance with timelines. If this is delegated to an external partner biostatistician, reviews the biostatistical deliverables by the assigned vendor
Provides input for pooling strategies for submissions and IND updates, and provides statistical input into the Investigator Brochure
Reviews sections of NDA/MAA submissions (including ISE, ISS, summary of clinical efficacy, summary of clinical safety, clinical overview, and any other specific sections of importance [e.g., cardiac safety report, abuse liability report, suicidality report, and risk management plan]) and attends and contributes to all related roundtable discussions
Works with submission teams to ensure proper responses to statistical related questions from regulatory authorities or Health Technology Assessment (HTA) bodies are delivered in a timely manner
Global travel may be required
Other duties as assigned by company
7+ (with Ph.D.) to 10+ (with Master’s degree) years in biostatistics within the biotechnology and/or pharmaceutical industry (including CROs) with a proven successful track record in pharmaceutical development and demonstrated leadership in clinical development programs
Understands the implications of the pharmacokinetic profile of a drug on the design of pharmacodynamics and Phase I-III studies, or vice versa
Able to coordinate a team of biostatisticians and statistical programmers in the execution of a clinical program to support therapy area biostatistical deliverables
Sound knowledge of the ICH guidelines. Understanding of the regulatory requirements from EU, US and Japanese health authorities, and of the submission process in each
Experience with NDA/MAA submissions
Good knowledge of advanced statistical methodology
Established experience in contributing to global scientific improvement/change initiatives
Good knowledge in SAS and/or R programming
Good knowledge in visualization and simulation techniques
Able to work under pressure and without close supervision
Able to explain advanced statistics in a non-technical manner to non-statisticians
Able to multi-task and anticipate future statistical needs and the maturity to work in a highly independent, self-motivated manner
Able to pro-actively propose and defend alternative and often innovative study designs and statistical methods
Is a keen learner. Shows an active participation toward learning new statistical concepts, and the relevant aspects of the disease area of the related clinical programs
Provides examples of being a self-starter who is self-directed and self-motivated without putting self first
Able to adapt to working in a multicultural global environment

137

Senior Biostatistician Resume Examples & Samples

M.S. or Ph.D. degree in statistics, biostatistics, or related field
3 years or more experience in a CRO or Pharmaceutical environment
Knowledge in applied parametric and nonparametric statistics and SAS programming skills
Should be able to translate clients’ needs into statistical practice and educate clients in the use of statistics

138

Biostatistician Resume Examples & Samples

Significant experience in analysis and reporting using statistical software required
Experience with SAS preferred
Design of Experiments (DOE) experience preferred
Experience in FDA submissions and in vitro diagnostic tests preferred
Interacts with development and clinical investigators to designs clinical trials with appropriate statistical methods and adequate sample size for statistical justification of clinical utility claims
Performs data analysis and prepares statistical reports of results
Performs Quality Control (QC) for statistical analyses by other biostatisticians to ensure analysis quality
Conducts randomization and blinding of samples
Evaluates databases and statistical analysis programs and interacts with computer groups to determine hardware/software compatibility
Maintains expertise in state-of-the-art data manipulation and statistical analyses
Manages technical aspects of project(s), as assigned
Knowledge in FDA guidelines for in vitro diagnostic devices and the required statistical basis for sensitivity, specificity, agreement rates, and reproducibility testing required for validation and FDA clearance and approval
Strong ability to collaborate across departments and interact with various levels in the organization
High attention to detail with skill in producing organized reports
Ability to write statistical code and documentation
Ability to work in a team-focused environment is essential, as all statistical analyses under design control require both lead statistical analysis and quality control (QC), each conducted by different individuals who must coordinate activities

139

Biostatistician Resume Examples & Samples

Develop new innovative statistical methodologies for environmental analyses
Perform analyses on data that includes discrete and time-series data sets
Write and execute statistical analysis plans for environmental studies
Develop and execute procedures to oversee data collection, quality screening, validation and maintenance
Analyze and interpret simple and complex data sets
Produce relevant statistics to describe and infer trends and patterns
Develop data visualization products
Produce reports and/or summaries based on results
Write sections of protocols that require statistical input
Participate in identifying and marketing new clients
Participate on proposal planning and writing teams
Provide statistical expertise to internal and external clients

140

Biostatistician Resume Examples & Samples

Provide statistical data analysis support for the NEMSIS National EMS Database. We maintain the National EMS dataset which archives over 32 million EMS activations each year. The dataset is publically available and often, researchers contact the NEMSIS TAC to request that we conduct statistical analyses that involve elements that we are prohibited from releasing publically due to State Data Use Agreements
Report Generation. In addition to the National EMS database, we also maintain the Utah State Trauma Registry. This position will become an expert user of Tableau software. This position will generate reports and interactive dashboards allowing users to evaluate specific areas of interest and conduct exploratory analyses using developed tools
Training with State EMS Data Managers and Local EMS Providers. This position will offer webinar training sessions to familiarize potential users with available interactive reports. In addition, this position will work with stakeholders to resolve technical issues, specialized reporting requests made by states and ensuring all tailored code projects for states allow for the import/export of data
Research Publication Support. This position will provide statistical and Table/Figure generation support for publications developed for peer review publication

141

Biostatistician Resume Examples & Samples

Production and/or QC of derived datasets and both simple and advanced statistical outputs using efficient programming techniques
Assist in the production of analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents
Provide training in statistical analysis to internal clients
Mentor and train junior members of the department
Support of Business Development, e.g. by attending and preparing bid defense meetings
2+ years of experience in a related discipline is required

142

Senior Biostatistician Resume Examples & Samples

Assigns and monitors activities of other project personnel
Assists in setting priorities of work to be done
Provides support and serves as a resource to biostatisticians, programmers, and others
Participates in training of less senior biostatisticians and other team members
Provides input into evaluation of their team members
Takes an active leadership role in the department
Serves on various departments and CCF committees
Takes an active role in departmental recruiting and search committees
Participates in evaluation of new hard/software products
Consults with investigators on issues of study design (e.g., helping to define hypotheses, determining data needed, determining the required sample size)
Develops data collection forms and randomization schemes and instructs investigators in their use
Reviews and prepares statistical and database management sections of internally and externally supported proposals prior to submission
Determines and carries out appropriate statistical analyses. Interprets and presents results along with an explanation of techniques used in written forms including memoranda and reports, abstracts for presentation and manuscripts for publication
At least three years of relevant statistical experience in medical environment

143

Biostatistician Resume Examples & Samples

Design clinical trials and provide sound statistical guidance on clinical development project
Provide sample size estimates for proposed studies
Oversee and monitor CRO performance on implementation of SAP
Write statistical section of study protocols, statistical analysis plans and study reports
Review and consult on CRF design
Develop clinical trial randomization
Review study protocols, CRFs, database structures, edit check specifications, analysis plans, study reports and annual reports
Lead study or project team in the review and discussion of SAP
Maintain study documentation of statistical analyses and supportive documents

144

Biostatistician Resume Examples & Samples

Consult with research investigators on research projects. 10%
Prepare data for analysis by selection of appropriate subjects and variables, merging data files, transformation of data, exclusion of outliers, etc. 40%
Perform statistical analyses to answer questions posed by investigators and in support of study grants. 25%
Prepare results for presentation in written or oral format. 15%
Participate in writing of manuscripts. 5%
Review literature and attend educational programs/seminars to keep abreast of current statistical techniques. 5%
Perform other related duties incidental to the work described herein

145

Biostatistician Resume Examples & Samples

Providing statistical input and analysis of experimental design and large clinical datasets
Performing analysis of clinical study data using a variety of statistical methods
Competency with statistical computer programming and tools
Postgraduate degree at PhD level in a related subject area or relevant research experience (see Additional Information)
A well-established expertise and significant proven portfolio of research and/or relevant industrial experience within the following research fields
Established national and growing international reputation within academic field
Proven substantial record of publications in high-impact national and international journals
Proven record of contributing and leading successful research bids
Proven ability to lead and develop a research team
Proven ability to attract MA and PhD students
Proven record of academic leadership
Relevant professional qualification(s)
Evidence of collaborations with industry
Proven ability to adapt to the changing requirements of the Higher Education community
Evidence of ability to participate in and develop both internal and external networks and utilise them to enhance the teaching and research activities of the School
Proven record of taking responsibility for academically related administration
1) in possession of a doctoral degree, independently of the time taken to acquire it, or have at least four years of full-time equivalent research experience

146

Biostatistician Resume Examples & Samples

Must be able to work on multiple tasks simultaneously and, as such, may have competing deadlines or time constraints
Assists in the preparation and submission of abstracts and manuscripts
Participates in grant preparation

147

Senior Biostatistician Resume Examples & Samples

Perform duties of a Project Statistician to support high profile international development projects/trials or marketed products as required. Participate in the International Project Teams in the role of a Project Statistician as required. Collaborate with members of Clinical Research and Marketing, the Statistical Expert Group (SEG), Team Member Medicine and medical subteams in planning clinical programs and outlining protocols conforming to company and regulatory agency guidelines and/or marketing and publication strategies. Mentor statisticians within project, who have less experience overall and/or in the therapeutic area
Direct analysis of data from major, prototypical phase II to IV trials incl. responsibility for program validation. Direct exploratory analyses to discover or define possible drug effects or claims
Prepare accurate, high quality reports of complex clinical trials for registration of drugs and biologics, publications and management. Guide other trial statisticians (TSTATs) in this task
Serve on internal Data Monitoring Committees (DMCs) or represent the company on external DMCs
Participate on working groups (internal or external) to promote harmonization efforts and visibility for clinical drug development, including methodological publications
Attends all the meetings related to the trial/project needing a statistical input (or send delegates) and send minutes to the team members
Assist the Head of programming and Head of statistics with the working of vendors, contractors in establishing procedures for programming and validating statistical analysis (writes the scope of work, prepare documents to be sent to the contract research organization (CRO). From a statistical perspective, is the primary contact for CROs (programming validation)
From a statistical perspective, is the primary contact for medical writing (or choose a designee)
Ensures that protocol objectives are met and project standards are maintained (also responsible to update the project statistical analysis plan when necessary
Ensures achievement of major statistical deliverables and milestones in coordination with other functions including Clinical Research, Safety, Statistical Programming, Data Management and Medical Writing
Provides and organizes statistical support for regulatory meetings, questions and submissions
Ensures efficient work within the team by setting priorities and avoiding overlaps between team members
Ensures good communication between team members

148

Senior Biostatistician Resume Examples & Samples

Act as Project Statistician for early projects, backup projects,or projects with established BI experience
Support Project Statisticians of high profile international projects in their responsibilities, especially in their statistical responsibilities in the planning and preparation of regulatory submissions and contribute to efforts on cross-trial planning and harmonization
Prepare accurate, high quality reports of complex clinical trials for registration of drugs and biologics, publications and management

149

Biostatistician Resume Examples & Samples

Good knowledge in applied statistics and data analysis methodology including categorical data analysis, survival analysis, etc
Appreciation of clinical research and drug development process
Appreciation of ICH guidelines, regulatory requirements and industry standards (e.g. CDISC) and awareness of industry practices related to statistical and programming activities desirable
Good time management and problem solving skills
Effective verbal and written communication skills including presentation skills
Patient / Customer-focused
Values-based
Credible and influential
Optimistic and positive
At least 3-5 years of statistical experience
Knowledge of basic statistical design and analysis, with ability to communicate statistical concepts

150

Senior Biostatistician Resume Examples & Samples

Responsible for development of Statistical Analysis Plans, to include statistical methodology, statistical programming procedures, definition of derived variables, data–handling rules and mockups
Responsible for Biostatistics’ deliverables within assigned projects
Perform QC/statistical review of all analysis datasets and data displays
Statistical analysis of clinical trial data and related decision-making
Responsible for statistical input to statistical reports and Clinical Study Reports; Authorizes final reports as one of Covance signatories
Provide statistical representation on multi-disciplinary team preparing protocol; responsible for statistical input; approves as signatory
Provide statistical input into design/review of format of CRFs/other disciplines’ activities and participate in interdepartmental processes
Supervision of less-experienced biostatisticians within project activities
Prepare randomization specifications; generate schedules; verify randomization components (specification and schedule). Provide input into planning activities related to the preparation of, distribution of and access to randomization and unblinding information
Project management activities for identified projects including financial, resource planning and utilization, timelines and milestone management
Take responsibility for overall status and quality of Biostatistics’ project documentation, including maintenance of hardcopy and electronic files
Independent peer review of statistical deliverables, e.g., protocols, Statistical Analysis Plans, Tables, Figures and Patient Data Listings, statistical reports, Clinical Study Reports
Provision of technical solutions and advice to Covance staff and to clients on statistical methodology and principles
Provide support for DMCs, ensuring maintenance of appropriate blinding
SAS programming and related activities for the presentation and analysis of clinical trial data
Ensure mechanisms in place to maintain flow of appropriate information between disciplines on project team
Contact with client across multiple disciplines
Assigned tasks related to the development of less-experienced staff within the department
Contribute to review and amendment of departmental processes and supporting documentation
Contribute to proposals activities and client presentations
Represent the department during project-driven client audits
Carry out all activities according to appropriate Covance SOPs, working within the framework of the Quality Management System and to GCP
Perform other duties as requested by management
3 to 5 years of postgraduate experience in the application of statistics to clinical trials for employees with a PhD in statistics subject; 5 to 8 years of postgraduate experience in the application of statistics to clinical trials for employees with an MA/MS in statistics subject
The ability to work to tight deadlines while maintaining high standards
SAS proficiency including use of a variety of statistical procedures e.g., non-parametric analysis, linear and non-linear models, categorical data and survival analysis
Ability to adhere to strict guidelines & codes of practice
A good knowledge of the overall clinical trial process
Experience in the preparation of Statistical Analysis Plans, analysis, reporting, etc
An evident appreciation of the possible impact of day-to-day activities and actions on Covance as a business

151

Senior Biostatistician Resume Examples & Samples

Lead development of statistical analysis plans
Oversee and conduct SAS programming
Needs a good understanding of CDISC
Contribute to protocol development
Assist in report and publication creation
Assist in proposals
Effectively work with internationally remote and culturally diverse teammates; and
Manage his/her capacity and utilization across multiple projects
Travel is estimated at
Clinical trials
Secondary database analyses (e.g., claims, electronic medical records)
Prospective studies (chart reviews, time and motion, surveys)
Working knowledge of intermediate-level analytic techniques to perform analyses of health services data (e.g., logistic regression, non-parametric methods, mixed models, general imputation methods), and at least 2 of the following: marginal structural modelling, survey analysis, mixed treatment comparisons, Bayesian methods, non-linear mixed models. propensity scoring, responder analysis, area under the curve, ROC curves
Good understanding of the clinical trial process and observational studies (e.g., Phase IV, registries, retrospective chart review, time and motion studies)
Good understanding of basic study designs (e.g., cross sectional, parallel group)
Ability to conceptualize the presentation of results (e.g., develop layout of tables and figures for inclusion in analysis plans)
Strong ability to program using the SAS language
Ability to clearly communicate written results in drafts of study reports, presentations, publications, and other key project deliverables
Ability to contribute to documented processes
Working knowledge of Microsoft Word, PowerPoint and Excel

152

Biostatistician Resume Examples & Samples

Interaction with members of assigned project teams from other disciplines
Preparation of Statistical Analysis Plans under the supervision of senior statistical staff
Assure quality of personal work
Perform QC/statistical review of data displays for study endpoints
Statistical analysis of clinical trial data using basic methodology, under the supervision of senior statistical staff
Preparation of sections of statistical reports, as well as input into Clinical Study Reports, under the supervision of senior statistical staff
Perform sample size calculations under the supervision of senior statistical staff
Generate randomization schedules from provided specifications
Maintain project administration files with regard to all documents produced by Biostatistics, including associated review, QC and project tracking information, and internal and external communications
Maintain electronic files generated in Biostatistics according to defined specifications and procedures, ensuring those of a temporary nature are deleted in a timely fashion
0 to 3 years of postgraduate experience in the application of statistics to clinical trials
Interpersonal and effective communication skills
Cooperative and team-oriented

153

Biostatistician Resume Examples & Samples

Preparation and review of Statistical Analysis Plans and Statistical Contributions, under the direction of senior Statistical staff
Statistical analysis of clinical trial data using basic methodology, under the direction of senior Statistical staff
Production of data tables and graphs to the required specification for clinical, pharmacokinetic and statistics reports
Generation of randomization schedules from provided specifications
May review the format of CRFs under the direction of senior Statistical staff
Perform sample size calculations as required
Maintain project administration files with regard to all documents produced by Biostatistics, including associated review, QC and project tracking information and internal and external communications
Provide statistical support to SAS Programmers
Scheduling of clinical statistical work to meet required deadlines. Ensuring that projects are completed in a timely and accurate manner
Liaison with internal and external clients, as required, with regards to the requirements for analysis, tables and graphs
Review of Clinical Study Reports
May authorize final reports as one of the Covance signatories
May perform QC of data displays for secondary efficacy and safety variables
Display interpersonal and effective communication skills. Co-operative and team orientated
Promoting a professional attitude at all times both internally and externally and dressing accordingly in an appropriate manner
Performs any other duties as assigned

154

Biostatistician Resume Examples & Samples

Assume the role of Study Statistician for assigned studies
Preparation and review of Statistical Analysis Plans and Statistical Contributions, with appropriate guidance from other statistical staff
Statistical analysis of clinical trial data using basic methodology, with appropriate guidance from other statistical staff
Preparation of randomization specifications and the generation of randomization schedules
Review of protocols, providing a statistical advice service for internal and external clients
Perform peer review of other Statisticians’ work
Perform QC of analysis datasets, data displays for secondary efficacy and safety variables
Interpersonal and effective communication skills. Co-operative and team orientated
Training of other members of staff within the department in statistical methods and programming techniques
Related experience or PhD degree in Statistics considered in lieu of experience
Skilled in the use of PC based statistical packages (e.g. SAS) and general computer operation
Programming experience is beneficial

155

Biostatistician Resume Examples & Samples

Analysis of large multilevel databases using statistical software
Execution of latent variable models, multilevel regression analysis, and other more sophisticated analyses
Coding variables and building regression models
Constructing multilayer datasets from multiple large datasets, data cleaning, quality checks, formatting and organizing analytic files
Manage the interpretation of analyses, publication of results, and preparation of grants
2 + years of experience with statistical programming
Strong knowledge of SAS and R
Proficiency in statistical analysis methods related to health research
Experience in assisting with manuscript preparation and/or grant applications
Prior experience in nutrition, biochemistry, physiology, and public health
Prior work experience related to nutritional and/or chronic disease epidemiology
Strong organizational skills and attention to detail
Excellent written and oral communication, and problem solving skills
Ability to work effectively with diverse groups
Doctoral degree in epidemiology, biostatistics, quantitative social science, or related field preferred
Self-motivated, able to work independently and with a team, and able to manage their time across multiple projects

156

Senior Biostatistician Resume Examples & Samples

Assist with the design and analysis of medical device clinical trials in humans
Perform statistical analysis and validate as defined in analysis plan
Assist with preparation of analyses that support Regulatory submissions for product approval
Provide under detailed supervision statistical support for peer-reviewed journal publications
Deliver results in a manner that is time-sensitive, high quality, proactive and communicative with collaborating entities and Stakeholders
Perform sample size and power calculations
Assist in review of CRFs and edit checks
Review and understand analysis plans
Write interpretation of results with oversight from supervisor
Work with data Management partners to organize timely and accurate data extraction from EDC (or other) system into statistical programs for analysis

157

Senior Biostatistician Resume Examples & Samples

Advanced knowledge of statistical methods for design and analysis of clinical and/or epidemiological studies
Knowledge of SAS software and general computing in the pharmaceutical/medical device area
General project and time management skills
Good oral and written communication skills; ability to clearly communicate statistical issues and methods to both statisticians and non-statisticians
Good collaborative skills and ability to work with a cross-functional team

158

Biostatistician With Sas Programming Resume Examples & Samples

Strong applied statistics background
Past experience as a clinical trials statistician preferred, although experience in a research environment would be considered
Strong SAS programming skills in a clinical data environment

159

Biostatistician Resume Examples & Samples

3-5 years of hands experience as a Biostatistician or Data Analyst utilizing SAS
Experience with SAS data analysis- descriptive statistics, factor analyses, generalized linear models and random effects model
Experience generating data reports and program data in form of presentations

160

Biostatistician Resume Examples & Samples

Uses data science to synthesize unstructured, disjointed information into meaningful, compelling narratives that facilitate development and refinement of health system strategy
Supports requests from health system entities by identifying potential data sources, gathering data, conducting statistical work and communicating findings and implications
Supports the collection of national, regional, and local data for benchmarking and comparative analytics
Keeps abreast of developments and changing technologies and applications via self- initiated professional development. Participates in continuing education courses, professional organizations, attends training and trade seminars, and maintains professional contacts in the community and the industry

161

Biostatistician Resume Examples & Samples

Provide data analysis support for researchers and biostatisticians in the research department by using statistical software
Produce tables and graphics for statistical reports using a SAS and other computer languages
Prepare datasets for analysis by merging files, creating analysis variables, editing data, and developing documentation
Assist with interpretation of analysis results
Design and implement appropriate data collection and quality control methods
Minimum one (1) year of experience in analyzing research data using statistical package(s)
Experience with medical or health research
Minimum one (1) year of related statistical consulting experience in healthcare or medical research areas
Knowledge and experience with SAS programming language
Experience in asthma research preferred
Fast learner, detail oriented, and a good communicator
Intellectual curiousity

162

Non-clinical Biostatistician Resume Examples & Samples

Engineering, MSc or equivalent in mathematics, statistics or biostatistics
At least 2 year’s experience within the pharmaceutical industry or equivalent experience
Ability to work in multidisciplinary team (task forces, working groups, team projects, some being remotely located)
Leadership capabilities within the group, give guidance to non- statisticians, provide feedback, engage
Good oral and written communication in English
PhD, MS or Diploma in Statistics, Mathematics or equivalent
Deliver statistical expertise to support, conduct, analyse and interpret outcomes from routine experimental studies and more complex problems within Research and Development
Provide input to risk/benefit on decision making
Provide statistical training to non-statistician
Uses a range of sources and methods to obtain information relevant to a particular task or activity to drive development of expertise and encourages discussions relating to the information
Optimizes solutions relating to specific issues using current processes/tools
Identifies new and less obvious solutions (in process & statistical methodology)
Actively contributes to implement solutions and improvements beyond own area of activity, transversally within Non-Clinical R&D Statistics
Promotes teamwork and works to establish consensus among team members
Ensure clarity in roles, responsibilities and objectives
Spends time to help others resolve technical problems

163

Biostatistician Resume Examples & Samples

M.Sc. or Ph.D. degree in Biostatistics or Epidemiology
2-4 years of experience as biostatistician in the Pharmaceutical field
Comprehensive understanding of applied statistical principles and modeling in the design and analysis of clinical trials / epidemiological studies
Experience in statistical or clinical trial methodology research and presentations on statistical methods, clinical trial design, and analysis in either observational studies or randomized studies
Knowledge in epidemiology (for the biostatistician position in epidemiology)
Proficiency in SAS (knowledge of other statistical software is an asset)
Good skill in written and spoken English
Ability to easily communicate with different functions: clinicians, scientists, data managers, scientific writers, commercials, etc. in an international, multi-cultural environment
Experience in cDISC is an asset

164

Biostatistician Manager for QC & Manufacturing Resume Examples & Samples

Deep knowledge of vaccine manufacturing environment, including excellent understanding of the framework within which a product has to be developed and maintained in compliance with specifications and regulatory requirements
Strong theoretical background and practical application of designs of experiments, multivariate analyses, complex mixed effect models, statistical process control on a wide variety of business issues
Demonstrated active participation to key business projects aiming at improving QC/Mfg capacity
Demonstrated knowledge of CMC or cGMPs, compliance issues, inspectional trends, industry quality assurance practices and systems
Very good command of statistical packages: SAS, Design Expert, Simca-P, Statistica and Pack Office, including VBA for Excel
Team management (9 people), including planning and coordination of statistical activities, management of deliverables and priorities, training/coaching, PDP and performance evaluation
Troubleshooting support in line with MPUs business needs, i.e., providing support to investigations in the context of deviations and task forces (improve of QC and MPU release/production capacity)
Analysis of scaling-up and manufacturing data to support product registration or product variation, adhoc support during inspections by regulatory authorities. Interact with Regulatory and Safety to define statistical content of complex documents
Support to key business projects, e.g., QIP, Crossbow, TQR, test critical parameter identification and trend, biological material management, implementing new statistical approaches and innovation in the business
Increase of statistical capability within GIO by giving trainings and developing tools to harmonize the collection, analysis, report and interpretation of data in the context of Periodic Quality Review
Internal and/or external networking to encourages reflection on the application and content of authorities guidelines, promote GSK Vaccines proposals, deploy best practices across the organization, including the creation and/or review of existing SOPs (e.g., set of product specification limits, comparability assessments, equivalence testing approaches for biological product validation)

165

Lead Biostatistician Resume Examples & Samples

Provide strategic & statistical input in defining discovery and early project activities
Within the context of biologicals product development, defines, recommends, analyses and interprets the statistical part of projects in order to guarantee the statistical reliability of the conducted studies and dossiers and to allow the world-wide registration in compliance with the clinical development plan, good practices (GCP, GSP, ICH, ...)
Close collaboration with R&D for the validation of assays, Safety for the safety review of our products and with Regulatory for the submission of new products
Spreads good statistical practices
Drive (search and/or develop) and Implement new statistical approaches, innovation in the business
Accountable for statistical expertise in bringing vaccines from Phase I to Phase II

166

Senior Biostatistician Resume Examples & Samples

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, & experience
Strong SAS programming skills (Proficient in BASE, STAT, MACRO and GRAPH)
Ability to review current processes and identify potential process improvements
Experience of a wide variety of clinical trials/designs and corresponding reporting of data
Experience in interpreting the results from statistical analyses of complex data
Proven management skills, as shown through management of multiple projects and/or staff members

167

Senior Biostatistician Resume Examples & Samples

Performs statistical analysis for pre-clinical,clinical, and post-marketing projects in support of product development and U.S. and international product registrations
Minimum 4years' experience in the pharmaceutical/biotechnology industry in support of clinical studies preferred
Good working knowledge of major statistical software packages (e.g., SAS, S-plus, R)is a plus

168

Senior Biostatistician Resume Examples & Samples

To apply solid knowledge of statistical methodology and experimental design to plan laboratory and field animal studies for biologic and pharmaceutical veterinary compounds/antigens/bacteria/viruses for Research and Development, Discovery, Pre-Clinical, Clinical Research, and Drug Metabolism
To support conduct of clinical trials by providing statistical input to study protocols, producing randomization codes, addressing data collection issues, and evaluating protocol amendments and deviations for effect on data analysis and interpretation
To co-develop standardized Case Report Forms (CRF) with Clinical, and develop/maintain databases to retain clinical data by following good Data Management practices
To statistically analyze clinical, laboratory, or production data, and prepare reports that easily and concisely present the reader with clear conclusions
To collaborate on R&D and Clinical study reports, and provide statistical review of externally generated reports
To support submission of study results to appropriate Regulatory Agencies including, but not limited to, United States Department of Agriculture (USDA), United States Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM), European Medicines Agency (EMA) Committee for Medicinal Products for Veterinary use (CVMP), and United States Environmental Protection Agency (EPA)
To interact with Regulatory, Legal or other authorities on statistical issues related to product development, registration, investigations, patents
To support Production, Quality Control, Analytical Testing, Process Control, Process Optimization, with statistical expertise, when possible
To support Commercial Operations and Marketing/Sales with clinical designs during development to achieve the desired product label, and with post-marketing studies, when possible
To collaborate with, Veterinarians, Project Managers, Laboratory Scientists, Clinical Research Managers, Clinical Research Associates, Data Managers, Data Entry Administrators, Pharmacovigilance, Auditors, Regulatory Affairs Managers and IT experts to professionally accomplish the above stated tasks in a proficient team-oriented manner, exercising strong interpersonal skills
To manage vendors/contractors hired for statistical or data management activities
5 or more years experience as Statistician in human or animal pharmaceutical industry
Ability to understand and implement regulatory regulations and company procedures
Ability to work independently and efficiently, in a project team environment
Must be able to speak and write English
Proactive, pragmatic, flexible, service minded and able to work under (time) pressure
Knowledge of USDA/CVB, FDA/CVM, EMA/CVMP and VICH Guidelines
Knowledge of Animal Health or Veterinary practices
Knowledge of Quality Control, Assay Development, Testing Procedures

169

Biostatistician Resume Examples & Samples

The ideal candidate will have a Master’s degree in Statistics with a minimum of 2 years relevant experience in statistical analyses, data management, and statistical programming
Experience in Health Economics or Outcomes Research and strong knowledge of Healthcare Industry is preferred
Broad experience in data analysis techniques, including, resource utilisation and patient reported outcomes analysis (and to an extent) mixed models, survival analyses
Possess strong analytical skills, excellent communication skills and client management skills
As a trusted advisor to clients, you are able to understand the needs of the clients, build client confidence, and manage their expectations with your expertise, gravitas and commercial acumen

170

Principal Biostatistician Resume Examples & Samples

Represent Biostatistics in meetings with cross-functional project/study teams, collaborate with team members to establish project/study timelines
Provide statistical input for protocol development to ensure adequacy of study designs (including sample size/power calculations), outcome measures/endpoints, and analysis strategies
Write/review statistical sections of study protocols and statistical analysis plans (including specifications for tables, figures and listings) for clinical study reports (CSR) and integrated summary documents
Collaborate with data management, clinical operations, and programming to develop and validate study-specific data capture systems
Perform/review statistical analyses, interpret results and present data to key parties of interest
Write/review the appropriate sections of the CSR and oversee the generation, accuracy and completeness of all statistical appendices
Participate in vendor evaluation/selection and manage vendors to ensure quality of all deliverables' and adherence to study timelines
Plan and manage Bio-statistics related submission activities and interact with regulatory agencies as needed
Collaborate with clinical scientists, thought leaders, and medical writers, both internally and externally, in the publication of study data
Stay current with new developments in statistics, drug development and regulatory guidance through literature review, conference attendance, etc

171

Biostatistician Resume Examples & Samples

Assist with protocol development, sample size calculation, protocol and case report form (CRF) review
Under supervision, act as statistical team lead for single studies
PhD in biostatistics or related field; Master's degree in biostatistics or related field and 1 year relevant experience; or equivalent combination of education, training and experience

172

Vaccines Principal Biostatistician Resume Examples & Samples

Provide statistical input into Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans
Understand regulatory requirements related to the specific therapeutic areas and the implications for statistical processing and analysis
Good analytical skills and project management skills
Prior experience with SAS programming require

173

Intern, Biostatistician Resume Examples & Samples

Perform literature reviews on current methodologies
Develop innovative statistical approaches and apply them to clinical trial data
Evaluate different statistical methodologies by simulations and/or real world clinical trial data
Discuss the properties and applications of different statistical methods
Present and write up research professionally
Learn the critical role and responsibility of biostatistics in biotechnology/pharmaceutical industry
Candidate must be enrolled in a graduate-level degree program leading to a PhD in Statistics or Biostatistics
Completed at least two full years of graduate studies
Minimum GPA 3.2
Legally authorized to work in the United States
Previous experience and proficient with SAS and/or R
Preferred candidate enrolled in an advanced degree program graduating in 2017 or 2018
Excellent analytical/problem-solving skills and research experience
Excellent programming skills in SAS and/or R
Good knowledge about biological science/medical science
Exceptional interpersonal, leadership, and project management skills
A desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families, and society

174

Biostatistician Resume Examples & Samples

Using statistical software to program basic and advanced statistical analyses
Data cleaning and management
Assistance in writing up results for presentation and publication
Meeting with investigators and multidisciplanary teams to review and advise on statistical analyses
Assisting the BECS on administrative matters, including coordination with other statisticians and investigators

175

Biostatistician Resume Examples & Samples

Collaborate with Sr. Investigators to develop and perform statistical analyses (including planning, programming, analysis, interpretation and writing of results) for investigational protocols, subgroup and post-hoc projects and registry databases ending with preparation of manuscripts, abstracts and presentations at scientific meetings
Determine and/or verify correct statistical testing to be performed in each analysis request
Possess a solid understanding of the purpose, objectives and goals of each trial
Rearranges data in a format that allows for accurate use as well as possible integration and pooling across trials
Assure the maintenance of an up-to-date electronic archive recording data requests, statistical analyses, results, and data transmissions performed
Maintain department service standards as outlined in the BWH Code of Conduct
Masters degree in biostatistics, statistics, or related field
High proficiency in statistical computing; SAS experience strongly preferred
Possess strong analytical skills
Possess managerial skills in order to interact with both with statistical staff, Sr. Investigators and other members of the internal and external research group
Detail and process oriented
Ability to manage multiple projects simultaneously, including both long-term and short-term projects
Ability to make decisions related to issues in the statistical group pending final approval from the Director
Demonstrated sound independent judgment and competencies in clinical research

176

Senior Biostatistician Resume Examples & Samples

Prepare statistical analysis plans (SAPs), designs shells for tables, listings and figures and performs statistical analysis
Develop and implement statistical analyses in support of clinical trials for regulatory submissions that conform to applicable ISO, GCP and 21 CFR guidelines
Lead SAPs and analyses in working with the Food and Drug Administration -this includes 510(k), Investigational Device Exemption (IDE), all supplements/amendments and responses to FDA questions, or any external/internal auditing group
Understands when to use the appropriate statistical methods
Implement various statistical methods to the design and analysis of clinical trial data
Develop and implement statistical analyses to support clinical project leads for submission of clinical publications and abstracts to journals and medical conferences
Work closely with clinical project leads, data manager , regulatory affairs to quantify clinical outcomes in a clear and concise manner
Provide guidance and support for clinical studies during the design stage, sample size requirements to analysis and outcome reporting
Provide significant input in the development and review of CRFs; edit specifications, and critical variable lists
Lead the data analysis of large commercial and national datasets ( e.g Premier Healthcare Database, NIS) to support the scientific publication efforts
Develop and implement DOPs and procedures to meet regulatory and company requirements
Conducts all job duties within context of Good Clinical Practice (GCP), 21CFR and according to company SOPs and applicable ICH/EMEA guidelines
Comfortable with scientific literature, read, interpret and explain
Provide internal statistical review requested by Senior Management. e.g in-depth evaluation of statistical methods/data from published literature
Represents the Biostatistics function in core team meetings
Can explain the results of their statistical analysis to a broad audience

177

Biostatistician Resume Examples & Samples

Provides basic statistical analysis support
Reviews data for discrepancies, interacts with data managers, and creates analysis datasets
Prepares and communicates statistical results in written and oral summary
Works collaboratively with supervising and other statisticians in supporting project needs

178

Biostatistician, Clinical Operations Resume Examples & Samples

Bachelor degree in Math, Statistics, Epidemiology, Public Health, or similar, with 3-5 years of experience required, Master's preferred
Advanced computer skills in SAS and/or SPSS required
Excellent proficiency in Microsoft Office Suite (Word, Excel, Access, Power Point and Visio)
Clinical/healthcare background a plus
Strong mathematical and statistical skills with strong emphasis on analysis of large databases
Critical thinking skills and demonstrated ability to focus on details
Ability to learn quickly and work on multiple projects simultaneously, and demonstrated ability to work in a fast-paced, demanding, and stimulating environment
Must be a team player and able to work independently as well as take direction from the supervisor

179

Principal Biostatistician Resume Examples & Samples

MS with 8 years or PhD with 6 years working in applied statistics, including publications
Ability to handle a large volume of highly complex tasks with little to no supervision
Proficiency and experience in SAS programming, and detailed knowledge of SAS procedures and other statistical software
Effective team player: willingness to go the extra distance to get results, meet deadlines, etc
Some knowledge of medical/biological terminology and clinical practice in relevant therapeutic areas is preferred

180

Biostatistician Lead Resume Examples & Samples

Masters in statistics, mathematics, epidemiolog
At least 5-year experience in pharmaceutical industry
Has been previously responsible for studies with different designs (dose range, superiority/non inferiority, futility rule,..)
PhD in statistics, mathematics, epidemiology
Ability to work in multidisciplinary team (e.g., give guidance to non-statisticians, provide feedback, engage), some being remotely located
Good oral and written communication in English including ability to explain difficult issues and situations clearly and ensures meaning is understood
Accountable for statistical expertise in bringing vaccines from early/late development to registration
Leader in providing innovative approaches to better design and analyse our trials and speed time-to-market
Provide strong arguments to support upper management decisions. Defend independently statistical positions in external meetings (IND, advisory board) and towards Health Authorities
Provide active statistical expertise to other department for solving emerging questions requiring specific and complex statistical expertise
Coordinate statistical activities related to the Franchise. Responsible for the statistical quality & delivery within the Franchise
Ensure consistency across the different product developments in the Franchise and across Franchise
Communicate highly technical issues to non-statisticians at senior management level
Create external network to develop and bring adequate statistical approaches in clinical developments, lead or contributor author on statistical/product development papers, develop collaboration with external experts to efficiently meet the Franchise objectives
Lead the deployment (development, build acceptance through external credits from experts or Authorities, implementation) of new methodologies within GSK Bio. May lead the development of new processes/tools
Influences new or reviewed Authorities guidelines in statistical approaches for products development
Pro-actively support the development of biostatisticians within the organization

181

Biostatistician Resume Examples & Samples

Master’s degree in Computer Science, Statistical Mathematics, Public Health or other related field and/or discipline
5 years of hands on experience with biostatistics
Experience with CDC surveillance systems required
Random digit dial dual frame sample design
Data manipulation
Editing
Imputation
Experience with weighting by iterative proportional fitting
Analysis and reporting
Training and system usage
Business analysis
Provide input on day-to-day technical and scientific planning, and management of State-based behavioral surveillance programs
Sampling, imputation, demography, logistic regression, multiple regression, trend analysis, life table analysis, multi-level modeling, weighting techniques, small area estimation and modeling
Other chronic disease, behavioral, and social science statistical techniques
Sample size determination, development of State telephone sample, weighting techniques, and analysis of questionnaires
Excellent oral and written communication skills; experience with written and oral presentation of data, ability to interact professionally active duty military staff and clients
Detail-oriented, organized, fast learner, meticulous, and able to work at a fact-pace with tight deadlines

182

Biostatistician Resume Examples & Samples

Masters in Statistics, Mathematics, Sciences
Responsible for a whole study from design to execution for different study designs
Use stat methodology to establish study strategy

183

Associate Principal Biostatistician Resume Examples & Samples

Develops, coordinates, and provides biostatistical leadership and support for related drug/vaccine projects in Late Development Statistics
Interacts with Clinical, Regulatory, Statistical Programming, Data Management, and other Merck Research Laboratories Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects. May interact with Contract Research Organization (CRO)
This position may serve as a statistical lead in project teams
The incumbent may initially work in a specific disease area but may have the opportunity to work in multiple disease areas
Is involved in clinical development planning to ensure that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs
Evaluates appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology
Working knowledge of statistical and data processing software e.g. SAS and/or R
Strong oral and written communication skills and able to function effectively in a team environment
Experience in oncology therapeutic area strongly preferred or relevant regulatory filing experience

184

Biostatistician Resume Examples & Samples

Master's degree in biostatistics, statistics, or a related field
3+ years of statistical experience with multi-center clinical trials, or equivalent collaborative statistical experience
Highly specialized and technical knowledge of statistical analysis techniques and principles including categorical data and censored failure time data analysis preferred; advanced computer skills and experience with major statistical computing packages preferred; effective oral and written communication skills (with the ability to effectively collaborate with study chairs, medical officers, protocol specialists and database managers) preferred; familiarity with medical terminology preferred
Experience with independently analyzing data from clinical trials using standard statistical techniques preferred; experience contributing to the writing of manuscripts, abstracts, and other publications documenting study findings preferred

185

Biostatistician Resume Examples & Samples

Execute study protocols for analyses of existing data
Review relevant clinical and methodologic literature to identify appropriate analytic approaches
Prepare written descriptions of study methods and results for inclusion in publications
Prepare tables and figures for publications and other oral presentations
Present and clearly describe study methods and results to colleagues
Support Clinical Affairs with medical writing; i.e. abstracts, publications
Perform literature reviews to support Clinical Affairs, Regulatory Affairs and Quality Assurance
Master of Science (MS) degree in biostatistics, statistics, or applied statistics, with a least 2 years of experience in health care, preferably in relevant clinical applications (e.g., cardiovascular disease and/or kidney disease)
Excellent understanding of applied statistics, including survival analysis
Aptitude with statistical software package(s) (required: SAS and SAS/STAT, optional: R)
Excellent problem-solving skills
Effective collaboration and communication skills

186

Biostatistician Resume Examples & Samples

Becomes familiar with the activities outlined in the department's Working Practice Documents and contributes changes as needed. Learns and follows departmental procedures for statistical analyses and programming work
Serves as a lead statistician on moderate and large projects
Leads a project team. Conducts team meetings, maintains project timelines, assesses resources needed, provides resources, and prepares the budget. Ensures that SOPs are being followed and that appropriate project documentation is ongoing
Coordinates with programmers and data management personnel as to database maintenance, updating and documentation. Provides guidance for database structures for analysis
Creates or provides specifications for analysis databases based on Data Management database
Provides sample size calculations and reviews protocols for completeness, appropriateness of clinical design, and sound statistical analysis
Develops statistical analysis plan, including table and listing specifications, and guide others on the team in its implementation
Programs/validates statistical tables with an emphasis on efficacy endpoints. Provides proper documentation and oversee the work of others who assist in programming/validating
Interacts with the sponsor on all aspects of the project
Provides general infrastructure support to the Biostatistics Department. Examples could include presentation/ teaching at the Bios Department meetings, contributing to other general department documents or policies, assisting with Bios newsletter, helping in Bios department libraries, or training of new hires. Provides input to the Director and Associate Directors as to hiring recommendations, department policies, and resourcing requirements
Strong SAS® programming skills (Proficient in BASE, STAT, MACRO and GRAPH) and understanding of database structures

187

Senior Biostatistician Resume Examples & Samples

Effective communication with various levels of personnel is required regularly
Work collaboratively with multiple stake holders to develop scientifically appropriate strategies
Effectively and persuasively presents statistical concepts and arguments to management, regulatory agencies, scientists and non-scientists
Experience working with complex problems where analysis of situations and data requires in-depth evaluation of various situations
Ability to exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results

188

Biostatistician Resume Examples & Samples

Five or more years of experience working on analytical projects for genomics or diagnostics
Experienced in standard statistical methods including hypothesis testing, regression analysis, linear and non-linear models, data aggregation and visualization
Strong R, SAS, or Matlab programming skill (including data graphing skill) is required
Experienced with one major programming language (e.g. JAVA, C/C++/C#, Python, Perl) in Linux is highly desirable
Comfortable with SQL relational databases for data management
Understanding of genomics, PCR, and sequencing technologies
Experience with FDA and/or CE/IVD regulations is a plus
Experience with CLSI guideline and/or clinical trial design is a plus
Willing to learn new methods and skills
Relevant MSc degree required, PhD preferred

189

Biostatistician Resume Examples & Samples

Support the researchers by providing professional knowledge and skills through consulting, evaluating, and analyzing all aspects of statistical application
Conduct sample size estimation and statistical power analysis to determine the minimal sufficient number of subjects required for the study
Select, run, and interpret statistical analysis for the data
Develop and implement statistical methodology and procedures to support the protocol
Communicate and interpret the statistical results investigators to ensure that data are accurately reported
Make technical judgments concerning intangible complex issues such as the validi ty of a scientific approach
Advises investigator on amendments and correctness for unanticipated problems during actual research
Manipulate large datasets as required in order to facilitate analysis
Assist investigators with database design and management as required
Performs other duties within the scope of work as assigned
10-15 years of related statistical analysis experience
Mastery of and skill in applying advanced statistical theories, principles, concepts, methods, techniques and practice
Knowledge and skills so as to provide advice and consultation on a variety of problems involving the theory or application of statistical methods
Working knowledge of U.S. Federal government regulations regarding the conduct of human clinical research
Skill to evaluate new statistical methods. Quantitative analysis expertise is required
Must be proficient in the use of SAS. Additional proficiency in SPSS, STATA and/or NCSS is also preferred
Skill to recognize the significant and critical factors in research to advise the investigators of such issues and develop and formulate computer instructions for utilizing the statistical software package for data analysis
Complete human protection training developed by the Collaborative Institutional Training Initiative (CITI) within one month from start date
Work requires concentration, periods of standing and walking on a regular basis. Must work well under pressure, often changing conditions and research workload

190

Senior Biostatistician Resume Examples & Samples

Work with clinical scientists, statistical programmers, clinical operations, regulatory affairs, and other statisticians to plan clinical studies, and to analyze and interpret clinical study data
Participate in new drug development programs as a Subject Matter Expert (SME) in statistics area
Produce the following study-related deliverables, either personally or by supervising CROs: appropriate sections of study protocols, case report forms, statistical analysis plans, data analyses, manuscripts, and sections of clinical study reports and registration documents
Keeps abreast of literature/advancements in science/medicine/technology in own and related fields of the drug development program
Provide a sample size based on the specification provided by clinical scientists
Develop analysis specifications and review/verify analyses and programming codes for quality assurance
Participate in development of standard reporting programs for clinical studies
Participate in development of standard CRFs for clinical data collection
Participate in regulatory submissions including CSR, IND safety update, Annual Report/PSUR, and integrated summaries of safety and efficacy in NDA and BLA

191

Senior Biostatistician Resume Examples & Samples

BS in Mathematics, Physics, or Engineering with a Masters in Statistics OR BS in Sciences and PhD in Statistics
4 plus years of experience as biostatistician in the Pharmaceutical field
Proficiency in SAS, R, JMP (knowledge of other statistical software is an asset)
Compliance with internal Standard Operating Procedures and regulatory guidelines
Rigor and discipline
Support, conduct, analyze and interpret outcomes from routine experimental studies and more complex problems
Ensure that scientific questions for research objectives are defined clearly and that statistical methods and analyses are optimally designed to provide statistical evidence to answer those questions
Propose and support the implementation of changes in process, statistical methods/policies within the team and on business partners as required
Propose and apply novel statistical approaches when they add value and insight. Keep abreast of new developments
Deliver statistical expertise within research and GLP environments

192

Biostatistician Resume Examples & Samples

Support researchers by providing professional knowledge and skills through consulting, evaluating, and analyzing all aspects of statistical application
Develop and implement statistical methodology and procedures to support research protocols
Communicate and interpret the statistical results with investigators to ensure that data are accurately reported
Make technical judgments concerning intangible complex issues such as the validity of a scientific approach
Advise investigators on amendments and correctness for unanticipated problems during actual research
Proficiency in SPSS, STATA and/or NCSS is preferred
Completed human protection training developed by the Collaborative Institutional Training Initiative (CITI)
Experience in a human subject research setting and experience in the US federal government system is highly desired

193

Non-clinical Biostatistician Resume Examples & Samples

University level in Mathematics, Sciences or Engineering with at least post-graduate in Statistics or equivalent statistical experience. PhD in Statistics is a most
At least 2-4 years of experience as biostatistician in the Pharmaceutical field
Comprehensive understanding of applied statistical principles and modeling in the design and analysis of laboratory experiments
Ability to easily communicate and work in collaboration with different functions: clinicians, lab scientists, scientific writers, etc. in an international, multi-cultural environment
Deliver statistical expertise to support, conduct, analyse and interpret outcomes from routine experimental studies and more complex problems
Work in collaboration with the lab scientists, technicians and statisticians in the team
Deliver statistical expertise within research and GCLP environments

194

Senior Biostatistician Resume Examples & Samples

Developing the statistical section of the study protocol and any necessary amendments, including performing exploratory analyses of past studies and reviewing of relevant literature for optimal sample size estimation
Preparing/overseeing the development of the randomization plan and it’s documentation
Developing the statistical analysis plan (SAP) and corresponding TFL shells (in-text and end-of-text) with TFL programming notes in support of IA, DMC, and CSR analyses
Developing cross-functional data review (XFDR) plan and leading blinded XFD reviews
Providing input to protocol deviation plan development and review
Providing input to SDTM/CDISC and ADaM programming specifications development and review, (e-)CRFs, data monitoring plan, data management plan and data validation plan development
Developing KRM and the Treatment Unblinding Plan
Providing support to CSR development
Serving as a key contributing member of project teams with other Study Execution Team (SET) functions responsible for meeting study objectives
Ph.D.in Biostatistics or related field and 0-4 years of work experience in the pharmaceutical industry, or M.S. in Biostatistics or related field and 3-6 years of work experience in the pharmaceutical industry

195

Biostatistician Resume Examples & Samples

Produce tables, figures and data listings using efficient programming techniques
Perform statistical analyses under close supervision
Assist in the production of statistical reports and statistical sections of integrated clinical reports
Check own work in an ongoing manner to ensure first-time quality
Communicate process improvement ideas within the department
Travel to, attend and actively contribute to all kind of client meetings as appropriate (e.g. presenting and discussing study results accompanying the Biostatistics Lead)
Additional responsibilities as defined by supervisor/manager
Prior experience with SAS programming desirable

196

Principal Biostatistician Resume Examples & Samples

PhD in Biostatistics/Statistics or equivalent or MS with 2-4 years of experience in clinical trial setting
Thorough understanding of statistical principles
Some knowledge of medical/biological terminology and clinical trial designs in relevant therapeutic areas
Conversant with SAS programming, and knowledge of SAS procedures and other statistical software
Able to deal with ambiguity

197

Senior Biostatistician Resume Examples & Samples

Lead project statistical support ensuring that needs are fully met by expert and timely statistical consultancy and support
Input into clinical research programmes and study protocols. Independently provide study design consultancy, decide on statistical analysis methodology, specifying the protocol statistical considerations section including the analysis plan
Review statistical considerations sections, results sheets and clinical study reports
Collaborate on research and development projects advising on study design, analysing and reporting results
Specify table templates, write analysis dataset specifications, analyse data, write clinical study reports, results sheets and data on file reports, disseminate study results with study teams and brand managers, write manuscript results sections for publication and critique competitor promotional material
Develop, test and run SAS programs for analysis datasets, report tables, graphics and statistical analysis, liaising with statistical programmers as appropriate
Deliver training and awareness sessions to research and clinical research staff at all levels
Identify and lead systems and process development to improve the efficiency and quality of work within the statistics function under the management of the Statistics Manager
Further develop knowledge of design consultancy and analysis methodology, and statistical software packages (e.g. SAS and Proc Statxact, MlwiN, Nquery, PEST, EAST, Quality Analyst)
Validate software, in the role of system owner or tester, and test SAS Macros, maintaining the required validation and testing documentation
To perform all activities in compliance with relevant GCP, GMP and Quality Systems standards and specifically with FDA Quality System Regulation (including 21CFR Part 11), EN46000 and ISO 13485. Lead development and maintenance of in-house programming standards in line with the above quality standards and regulations
To ensure full commercial value is realised from the clinical trial evidence through promotional material and publications in liaison with the CRAs/CPMs and commercial

198

Biostatistician Resume Examples & Samples

Strong and practical experience in study design and statistical analyses
Strong knowledge of statistical techniques such as logistic regression, Cox regression,
Demonstrated statistical/analytical and reasoning skills to perform high-level problem solving
Has a thorough understanding of analysis, coding, testing and project methodologies
A high level of patient and data confidentiality and security must be maintained

199

Senior Biostatistician Resume Examples & Samples

A PhD degree in statistics or biostatistics with 0-2 years working experience
The candidate should have in depth understanding of statistical concepts and techniques, ability to perform statistical research and simulation
The candidate must have excellent communication and interpersonal skills, be highly self-motivated, and have ability to successfully conduct multi-tasks, work independently with minimal supervision, pay attention to details and work well in a team environment

200

Biostatistician Resume Examples & Samples

Responsible for the design, analysis and reporting of experiments that address a wide range of problems including, but not limited to, any of the following
Advanced degree in either Biostatistics, Statistics or Mathematics
Normally requires Ph.D and 8+ years or Master’s and 11+ years of experience, preferably with experience applying statistical methodology in a biotech, diagnostic or life sciences environment
Solid grounding in statistical theory and familiarity with current developments in statistical methods
DOE
Process development, validation, and troubleshooting
Complex process optimization
Statistical process control
Specification setting
Proficient in SAS or S+/ R; knowledge of a scripting language and/or SQL desirable
Experience working on distributed Linux environment desirable
Familiarity or experience in environments regulated under FDA , CLIA , or ISO

201

Biostatistician / Epidemiology Expert Resume Examples & Samples

Provide epidemiologic support for enhanced DRH surveillance activities
Provide epidemiologic support and guidance to states and CDC staff analyzing surveillance data
Perform statistical analysis on data collected through the surveillance system using SAS and SUDAAN
Apply statistical methods to describe data, estimate parameters, and test hypotheses
Conduct advanced analyses using ANOVA, simple and multiple regression and other modeling techniques
Coordinate research and capacity building projects with epidemiologists to help define project’s goals and objectives and define landmarks to assess progress toward achievement of these goals and objectives
Provide statistical support to fulfill the requirements to assure the scientific rigor of studies and investigations relating to reproductive health
Work with the CDC liaison in collaboration of national, state and local partners
Participate in activities targeting capacity building such as training activities and journal clubs focused on statistics and epidemiologic methods
Publish reports of high scientific merit in peer review journals or other publications
A Bachelor’s Degree in Biostatistics (additional experience may be substituted in lieu of education)
3-6 years of experience applying advanced statistical methods to complex surveys and longitudinal data
Experience completing complex linkages of large databases; analysis of Population Attributable Fractions (PAF)
Expertise in the design and execution of specific research and statistical activities including but not limited to the design and analysis of epidemiologic surveillance systems, surveys, and observational studies
Data Analysis

202

Biostatistician Resume Examples & Samples

Supports post-hoc analysis of Gemini Data
Supports RWE data analysis and study design
Supports interventional MACS study design and analyses
Supports Large Data exploratory analyses for disease and biomarker development
Reviews project protocols, writes protocol statistical analysis sections, including sample size calculations or simulations
Develops statistical analysis plans for clinical trials or registry studies with full documentation
MSc in Biostatistics or similar is required (PhD in Biostatistics or similar is preferred)
LI-TC2-EUR

203

Senior Biostatistician Resume Examples & Samples

Develops Statistical Analysis Plans (SAPs) and leads the execution effort for assigned studies
Develops statistical programs as necessary to ensure the accuracy of the planned and completed analyses or exploratory analyses
Reviews protocols and contributes to protocol statistical analysis sections, and generates study randomization scheme when appropriate
Author results sections of the clinical study reports and supply statistical input for PMA submissions and in response to regulatory questions
Provides independent validation of the statistical content in study documents including randomization, study reports, briefing documents, patient brochures, publications, and other content delivered to external entities
Represent Biostatistics in study team and work with management and other team members regarding study status and timeline update
Participate in developing case report forms and clinical database and data cleaning to ensure quality data collection
PhD in Statistics/Biostatistics and 2-3 years of clinical trial experience within the medical device, pharmaceutical, biotech industries
Masters in Statistics/Biostatistics and 5+ years of clinical trial experience within the medical device, pharmaceutical, biotech industries
Must be proficient with SAS; proficiency with additional software packages such as R or S-Plus desired
Must have sound knowledge of theoretical and applied statistics
Must have sound understanding of regulatory guidelines (e.g., GCP, FDA) as they apply to a Pharmaceutical/Medical Device research setting
Effective skills in communication and team collaboration

204

Associate Biostatistician Resume Examples & Samples

Serve as a lead statistician on small and simple projects with supervision
Create analysis databases from Data Management database. Coordinate with programmers and data management personnel as to database maintenance, updating and documentation
Develop statistical analysis plan including table and listing specifications
Program/validate statistical tables. Provide proper documentation and oversee the work of others who also assist in programming/validating
Participate in sponsor meetings. Interact with other departments, such as data management, clinical, and medical writing
BA/BS degree in statistics, biostatistics, mathematics or related field
Minimum 2 years experience (or Master's degree)
Strong SAS programming skills including a thorough understanding of macros, SAS/GRAPH, SAS/STAT, and data step programming
Knowledge of clinical trials database structure
Positive attitude and the ability to work well with others

205

Lead Biostatistician Resume Examples & Samples

A Master’s degree in Statistics, Biostatistics, or Applied Statistics with at least 6 years of experience OR a Ph.D. with at least 4 years of experience performing statistical analyses in a regulated environment, preferably medically related is required
Demonstrated technical experience in preparing statistical deliverables on time is required
Ability to assist in selecting and applying statistical methods in the field of application is required
Experience with survival analysis, longitudinal data analysis, and other current statistical methodologies is required
Proficiency in SAS and Microsoft software (Word, Excel, PowerPoint) is required
Ability and willingness to travel up to 10% is required
Familiarity with other statistical packages and power analysis software is required
Knowledge of Bayesian statistics, meta-analyses, or simulation techniques is required
Ability to contribute to strategic planning is preferred.Biostatistics

206

Senior Biostatistician Resume Examples & Samples

A Master’s degree in Statistics, Biostatistics, or Applied Statistics with at least 4 years of experience OR a Ph.D. with at least 2 years of experience performing statistical analyses in a regulated environment, preferably medically related is required
Knowledge of US law, regulations, and FDA guidance covering good clinical practice (GCP) is required
Thorough understanding of descriptive statistics, power/sample size analysis, hypothesis testing, non-parametric, and multivariate statistical tests is required
Familiarity with other statistical packages and power analysis software is preferred
Knowledge of Bayesian statistics, meta-analyses, or simulation techniques is preferred
Understanding of the processes involved in strategic planning is preferred.Biostatistics

207

Associate Biostatistician Resume Examples & Samples

Becomes familiar with the activities outlined in the department's Standard Operating Procedures and Working Practice Documents and contributes changes as needed. Learns and follows departmental procedures for statistical analyses and programming work
Serves as a lead statistician on small and simple projects with supervision
Creates analysis databases from Data Management database. Coordinates with programmers and data management personnel as to database maintenance, updating and documentation
Provides sample size calculations and review protocols for completeness, appropriateness of clinical design, and sound statistical analysis
Develops statistical analysis plan including table and listing specifications
Programs/validates statistical tables. Provides proper documentation and oversees the work of others who also assist in programming/validating
Prepares and reviews reports, including interim reports, final Integrated Clinical and Statistical Reports, Integrated Summaries of Safety, Integrated Summaries of Efficacy, and other documents and manuscripts. Contributes to the statistical methods section and verify for completeness and consistency for report
Participates in sponsor meetings. Interacts with other departments, such as data management, clinical, and medical writing
Provides general infrastructure support to the Biostatistics Department (presentation / teaching at the Bios Department meetings, contributing to other general department documents or policies, assisting with Bios newsletter, or helping in Bios department libraries)
Strong SAS® programming skills including a thorough understanding of macros, SAS/GRAPH, SAS/STAT, and data step programming

208

Clinical Biostatistician Resume Examples & Samples

Attend internal team meetings and relevant client team meetings for assigned project(s)
Assist with the coordination of the documentation and archival of SAS programs, specifications and deliverables for assigned project(s)
Coordinate with SAS programming staff to ensure the accurate programming of SAS clinical data extracts and data displays
Ability to synthesize results in graphic, oral, and written reports
Experience with SAS Base and SAS Stat
Experience with other statistical software packages, such as N-Query, S-Plus
Excellent organizational skills, highly detail-oriented
Willingness to learn new statistical methodology, new technology, and new tools that will facilitate the clinical trial process

209

Biostatistician Resume Examples & Samples

Builds documentation and organizational skills to effectively return to a trial or manuscript project after long intervals. Contributes meaningfully to discussions of analyses and identifies next steps for analyses
Designs analysis data set specifications through writing own SAS and or S-plus code, find errors, correct and validates output and results
Performs complex programming such as data transposition and macros. Programs analysis datasets using SAS; combines multiple disparate raw databases and derives analysis variables accurately. Uses complicated SAS procedures and options and programs with increasing efficiency
Work together with laboratory PI, Collaboration for AIDS Vaccine Discovery (CAVD) and HIV Vaccine Trial network (HVTN) as well as with Duke Human Vaccine Institute statistical cores and laboratories to manage, track and quality control datasets for assays assessing the antibody Fc- mediated functions
Interact with scientists performing the assays and the statistical cores to further develop processes and tools for optimal data analysis of large high content data sets
Collaborate with the statistical programming units from the different networks to analyze large data sets. Provide feedback to the statistical programming unit and to the investigators or program management as appropriate to refine queries and analyses, developing reports on new data queries as appropriate
Drafts statistical sections for study synopses, data summaries and manuscripts. Understands the contracted scope of work and forecasts monthly hours expected to complete each trial/project
Drafts statistical sections for study synopses and protocols. Understands study data and the intricacies of the process through which it is being collected
Handles and secures highly confidential and sensitive analyses and documentation. Collaborates closely with investigators, sponsors, and other trial leadership to ensure that trial/project results and conclusions are presented accurately and without bias
Leads or participates actively in the statistical team responsible for designing and validating analysis data sets, programs, and statistical output products(tables, listings, figures). Adheres to standard operating procedures (SOPs) of the functional department as they apply to documentation and validation of clinical research statistics
Understands guidelines from FDA, ICH, EMEA, NIH or other regulatory agency as they apply to statistics and programming expectations for each project
Collaborates effectively with a variety of types of individuals, programmers, statisticians, research technicians, quality assurance unit, and project leaders
Manage project responsibilities with decreasing levels of supervision and takes initiative to complete project specific responsibilities with minimal supervision
Demonstrates progress in ability to multi-task
Oversee the use of the custom tools for binding antibody multiplex assays. Interact as primary liaison with lab data operations and statistical teams of an off-site collaborator (daily) to resolve data uploads, corrections/modifications and QCs
Evaluate system problems, develop and implement corrective action plans
Develop and implement systems for data quality control. Implement performance metrics for measuring workflow efficiency and generate work-flow analysis on a per-study and per-technician basis
Create binding antibody data sets from these data in conjunction with the appropriate oversight groups (e.g., the Quality Assurance Unit) to maintain Good (Clinical) Laboratory Practices
Maintain and query databases of binding antibody Fc-mediated functions data including all quality control parameters (including Levey-Jennings tracking, preset positivity criteria, and validation data). Assist with the implementation of new data queries as requested

210

Senior Biostatistician Resume Examples & Samples

Demonstrate excellent leadership and communication skills
Possess knowledge of regulations and follow appropriately
Ability to work independently on routine assignments, under supervision on new assignments
Ability to identify and resolve areas of concerns. Work with others as necessary

211

Biostatistician, / Manager of Orientation Resume Examples & Samples

Clinical and observational study development and review
Forms and database design and review
Development of analysis plans; and programming
Data analysis and report writing
3+ years of related statistical experience, including with multi-center clinical trials, or equivalent collaborative statistical experience required
Background in biology or bacterial infectious diseases preferred
Prior experience with MS Office (Word, Excel, PowerPoint) preferred
Collaborate with the CBAR Associate Director of Training, the CBAR Biostatistics Training Coordinator and the CBAR Programming Training Coordinator in maintenance of orientation materials, and keeping targeted areas of the CBAR web up to date
Compile and periodically update contents of written and electronic orientation materials provided to new hires, with the support of the Administrative Team
Maintain comprehensive standardized expectations for mentors, topic experts and supervisors
Work with new hires, supervisors, mentors, and topic experts to oversee the new hire’s education and evaluation of skills during the first year of employment

212

Biostatistician, / Manager of Cdisc Training Resume Examples & Samples

SDTM Modeling
Study Monitoring
Experience developing training materials preferred
Overseeing the development, posting and maintainance of training materials on the CBAR web for use by statisticians and epidemiologists developing protocols under the CDISC paradigm, including guidance for protocols, design of case report forms, modeling of SDTM tables, and creation and use of analysis (ADaM) datasets
Developing, maintaining and posting CDISC orientation training materials for new MS and PhD statisticians and epidemiologists starting work on CDISC studies
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213

Senior Biostatistician Resume Examples & Samples

Support other statisticians by cleaning data, creating exploratory tables and listings, reviewing output, and validating analyses
Assist with sample size and power calculations
Review CRFs and edit checks
Assist in developing Statistical Analysis Plan and create table, listing, and figure shells
Validate statistical analysis as defined in SAP
Able to code statistical analyses and familiar with good coding practices
Provide biostatistics support for study team
Assist in interpretation and writing of results
Support preparations for interactions with regulatory agencies
Read and understand Medical/Clinical literature as required by duties
Assist in maintenance of department tools, templates, guidelines, SOPs, and systems
Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
Develop knowledge of FDA regulations, ICH GCP guidelines, the drug development process
Develop and increase knowledge of relevant statistical software
MS or PhD in Statistics, Biostatistics, Epidemiology or related field
Knowledge and experience using statistical programming software

214

Biostatistician Resume Examples & Samples

Work with investigators to assist in developing quality procedures for data collection, study design, and statistical analysis
Write efficient SAS/R code, complicated SAS procedures and options, SAS macros, and R functions
Prepare tables, analysis results and statistical procedures for different projects
Provide help in writing statistical method section for protocols or grant application
Master’s degree in biostatistics or statistics with 8+ years of experience working in a biomedical research environment
At least 5 years of experience in analyzing data using statistical package(s) SAS, R, PLINK
At least 5 years of experience with Unix/Linux system and Perl/Python programming
Familiar with asthma and COPD phenotypes and sub-phenotyping approaches such as cluster analysis and discriminant analysis
Familiar with genetic data analysis, such as genome-wide association analysis and microarray expression data analysis

215

Biostatistician Resume Examples & Samples

Provide statistical expertise for clinical study designs - Understand the therapeutic area, the clinical use of the product and relevant literature to collaborate in the creation of the study design, including authoring the statistical section of the protocol to assure meaningful study results. Based on the intent of the study and the clinical endpoint, determine the appropriate study design, the sample size, randomization/blinding scheme, and the method of statistical analyses required to analyze the study data. Provide input to the case report forms to ensure that required information is collected
Prepare and analyze study data – Create edit checks to assure data quality. Work with Clinical Research Associates and Data Management to generate and resolve data queries. Develop statistical programs to analyze data from both small and large clinical studies according to the protocol
Document and Communicate Study Results - Document and report Clinical Study results in accordance with the protocol. Summarize study results and collaborate with team to translate into clinical relevance. Review/co-author resulting manuscripts and posters to present results to various internal and external audiences
Master’s degree or higher in statistics or biostatistics from an accredited institution
Coursework or experience that includes clinical trials, survival analysis, linear models, non-parametric testing, Bayesian methods, adaptive designs
SAS, R, or C programming experience
Analytical problem solving skills
Experience in clinical research

216

Senior Biostatistician Resume Examples & Samples

Act as the lead statistician on multiple clinical research projects
Contribute to the protocol development, including the experimental design, randomization, sample size calculation, statistical methods, and prepare the statistical section
Prepare detailed statistical analysis plans (SAP's), and develop/QC the derived datasets and TFLs
Prepare and analyze the bioinformatics data or clinical data for posters and manuscripts
Liaise with contract research organization (CRO) trial statisticians and data managers
Perform the analysis on the commercial/marketing data as needed
Ph.D. degree in Biostatistics/Statistics or a closely related field
At least 2+ years of experience in a clinical trial setting (biotech, pharma or CRO)
Must demonstrate statistical skills and knowledge of clinical trial methodologies
Must have experience with SAS programming and R/S language
Experience in oncology trials preferred
Excellent practical, organizational, interpersonal, oral and written communication skills are a must

217

Senior Biostatistician Resume Examples & Samples

Experience in the statistical planning, study design, analysis, reporting and communication of data and analyses of clinical studies from all phases of clinical development and post-approval
Working knowledge of SAS, including familiarity with SAS/GRAPH, and SAS/MACRO. Knowledge of R programming a plus
Ability to learn and apply standard and complex statistical methodology and simulation methods
Familiarity with industry standards for database design (CDISC: SDTM, ADaM) a plus
Excellent analytical, problem solving, communication and organization skills with the ability to work simultaneously in multiple tasks and teams
Flexibility to deal with multiple priorities, detail-oriented, and ability to work well under pressure Ability to work in a collaborative environment and a drive to learn and improve skills
Ability to communicate statistical concepts and interpretations to non-scientists
MS in statistics, mathematics or related field with at least 5 years of experience or PhD with at least 3 years of relevant experience in biotech/pharma or CRO
Strong analytical skills and demonstrated experience in gathering, analyzing, interpreting, reporting and presenting data
Ability to anticipate challenges and defend positions with factual information
Overnight travel up to 10%

218

Biostatistician With Sas Programming Resume Examples & Samples

With supervision by a more senior statistician or head of Biostatistics, produces synopsis, statistical section of the protocol, and SAP for specific studies
Participates in programming activities (analysis files, TLFs, randomization, …)
With supervision by a more senior statistician or head of Biostatistics, completes the statistical section of the iCSR
Reviews and approves study-related documents (CRFs, DEPs, …)
With supervision by a more senior statistician or head of Biostatistics, computes sample sizes, discuss trial design, and creates randomization
In collaboration with the programmers, ensures that statistical programs are developed, tested and validated prior to the target analysis date
3-6 years of relevant experience

219

Biostatistician Resume Examples & Samples

PhD in Biostatistics, statistics or a statistically related field
6 to 8 yrs direct experience in data base management, advanced statistical analysis, presentation and word processing software
Excellent written and verbal communication skills are essential, including developing and conducting training on biostatistics
Publication history is expected
Ability to work independently is essential, as well as effectively interact with research scientists and clinicians in a team environment
Prefer prior knowledge of immunotherapy
Prefer skills programming in SAS or R
Strong organizational skills and ability to meet deadlines

220

Biostatistician Resume Examples & Samples

Ability to independently pick and carry out an appropriate statistical analysis plan for the specific research question the PI would like to address
Knowledge of basic research design and methodology
Knowledge of fundamental statistical concepts and modeling techniques
Demonstrated analytical skills to problem solve effectively Knowledge of SAS and STATA statistical package desired
Knowledge of database management programs such as Microsoft Access and RedCap

221

Biostatistician Resume Examples & Samples

Proficiency in R statistical programming
Knowledge of data structures and algorithms
Proficiency in statistical analysis
Knowledge of web database development and large-scale data visualization
Knowledge of study design and research methodology
Experiences in large-scale comparative analysis of human and animal datasets
Strong working knowledge of life science and clinical research
Strong background and experience on genomic, proteomic and metabolomic studies and omics data analyses
Strong background in computation and programming
Must be able to take initiative and work independently and as part of a large research team
Excellent communication skills (oral and written) and analytical abilities are highly valued

222

Research Biostatistician Resume Examples & Samples

Provide expert statistical consulting for complex studies to Core clients
Provide consultation to Core clients on study design, sample size calculations, selection challenges
Provide consultation to Core clients on grant proposals needing biostatistical expertise
Provide consultation to Core clients on statistical analysis using the appropriate computation and graphical software
Maintain current knowledge of novel biostatistical methods
Maintain current knowledge of software that advances clinical/translational research
Prepare and conduct training/classes/outreach for the Biostatistical Core clients

223

Senior Biostatistician Resume Examples & Samples

Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and B&SR team. Meet established KPIs. Timely and high quality completion of Biometrics deliverables according to established objectives. Novartis is an Equal Opportunity Employer.Novartis is an Equal Opportunity Employer
Knowledge and expertise in Statistics and statistical software packages (e.g. SAS, S+, R)
Good communication and interpersonal skills 4. Ability to work well in a team

224

Biostatistician Resume Examples & Samples

Serve as a thinking and planning partner for GMA TA head. Obtain and manage flexible statistics resources to support all GMA activities
Provide statistical expertise for GMA activities including publications, GMA interventional trial designs, real world data analysis, etc
Ensures that technical and scientific standards within Statistics meet current industry trends
Advises Statistics leadership and project teams on innovative statistical methodology to increase clinical trial efficiency and soundness of publications
Monitors and influences advances in statistical and clinical trial methodology and serves as internal expert for the Global Statistics Organization with high degree of accountability
Oversees and monitors strategic initiatives aimed at improving decision-making and quality of deliverables
Identifies and collaborates with external statistical experts for issues related to design and analysis methodology for GMA projects
Critically reviews technical and scientific reports from external sources and provides input to the project team as appropriate
Conduct original research on relevant statistical topics focusing on current industry trends and coordinates learning/training opportunities within Statistics and for other functional areas
PhD in statistics or biostatistics with minimum of 13 years of relevant experience or MS in statistics or biostatistics with minimum of 15 years of relevant experience
Expert knowledge of statistical design/analysis methodology including latest developments and reporting procedures
Active in statistical/pharmaceutical professional organizations at regional or national level
Proven original research capability with a track record of statistical publications
Proven collaborative research capability with a track record of medical/public health publications
Ability to convey statistical argument and concept to influence audience at all levels and with diverse disciplines
Advanced knowledge of the pharmaceutical industry
Advanced knowledge of FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials
Ability to engage in statistical discussions with Regulatory Authorities
Excellent oral and written communications skills

225

Principal Biostatistician Resume Examples & Samples

You will perform statistical activities in support of development, validation, and post-marketing studies, including protocol and statistical analysis plan development, data analysis, preparation of final study reports, and contribution to external presentations and publications
Represents the statistics function in clinical development teams, medical affairs, and marketing/commercial activities
Provides strategic input to the project teams and is a major contributor to the design of clinical studies
You'll work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises discernment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
Interacts with external clinical and statistical collaborators
No direct management responsibilities but may mentor less senior personnel
Ph.D. in Biostatistics/Statistics
A minimum of 8 years of relevant work experience
Sound knowledge of theoretical and applied statistics
Experience analyzing time to event data from clinical trials and observational studies
Strong statistical programming and analysis skills in SAS
Experience in publishing the results of clinical, epidemiologic or genomic studies
Excellent oral, written, and presentation skills
Professional manner with the ability to communicate effectively throughout all levels of the organization
Able to work in a multi-disciplinary team including scientists, pathologists, and oncologists
Demonstrated ability to interact with and influence internal and external collaborators on study design, analysis methods, and interpretation of study results
Able to prioritize and work towards results with a strong emphasis on quality
Experience in statistical analysis in oncology and clinical diagnostics
Familiarity with genomic assay development
Experience working in the FDA regulated industry
Experience using R

226

Director, Biostatistician Resume Examples & Samples

Review publications and clinical study reports
Travel to, attend and actively contribute to all kind of client meetings as appropriate (e.g. discussing analysis concepts, presenting and discussing study results)
Ability to work independently and Good mentoring/leadership skills

227

Associate Biostatistician Resume Examples & Samples

Serve as a lead non-clinical statistician on projects with supervision
The major responsibility is to support the development and routine operation of vaccine and biologics assays
Provide statistical support to experimental design, data analysis, assay validation, scientific research and publication, and assay development
Prepare and review reports and protocols. Contribute to the statistical methods section and verify for completeness and consistency
Create SAS programs, graphs, and tables to perform and interpret analyses
Participate in internal meetings. Interact with multiple departments including data management, labs, and IT
Analyze Quality Control data to identify trends or anomalies
Provide training and support to scientists and other non-statistical professionals
1+ years experience in a CRO, pharmaceutical or similar regulatory environment preferred

228

Expert Biostatistician Resume Examples & Samples

University degree in Sciences, Statistics, Mathematics or equivalent Master in Statistics, Mathematics, Epidemiology or equivalent
At least 5-year experience of pharmaceutical industry
Experience in SAS software and sample size computation for standard designs
Ability to work in multidisciplinary team (eg give guidance to non stat, provide feedback, engage) , some being remotely located
Seeks information from the internal and external environment to understand the wider business, scientific and/or commercial context
Develop solution for non standardization situation (process & stat method)
Actively contributes to set up standard
Provide statistical expertise in specific topics and training of peers
Demonstrates experience in leading working groups; motivates other team members by involving them in issues that affect them
Acts as a mentor. Takes personal responsibility for supporting and developing others in the team
Interact and influence to build non standard solution
PHD preferred

229

Biostatistician Resume Examples & Samples

Consults with medical residents and faculty on the design, conduct, analysis and reporting of research projects
Has a crucial role in Value Institute projects that support and improve hospital Service Line Operations
Performs statistical data analysis for clinical outcomes, performance improvement data, and research projects
Oversees quality of data collection methods, data entry, and other factors which will affect data reliability
Participates in the design and implementation of biomedical research, projects that improve the delivery of healthcare and data collection efforts undertaken by medical/dental staff physicians, residents, program directors, and employed staff
Provides technical assistance to other CCHS departments/programs involved in research-related activities
Interpret statistical evidence through writing of internal reports and development of peer reviewed manuscripts
Master's degree in Biostatistics/Biometry, Epidemiology, Public Health or related field (PhD preferred)
Knowledge of epidemiologic principles and statistical methodology used in epidemiologic research
Knowledge of and skill using statistical computer software packages (e.g., R, SAS, S-Plus, Stata, SPSS)

230

Principal Biostatistician Resume Examples & Samples

Collaborate with internal program staff and sponsors on the implementation and analysis of statistical aspects of research protocols
Provide statistical consultation for clinical programs, including but not limited to protocol development, randomization, sample size assessments, efficacy evaluations, and data review
Define and manage project timelines for specific projects, and ensure that project timelines are met for both internal and external clients
Ensure that project tasks are completed with superior quality for both internal and external clients
Review, approve and develop, as needed, the statistical analysis summary and analysis plans, including textual description of planned analysis and mock-ups of data displays
Oversee and/or perform statistical analyses, including hypothesis testing and modeling
Interact with Medical Writers to ensure appropriateness of data inferences and/or write pertinent sections of a clinical study report
Interface with clients and/or regulatory agencies as the project biostatistician
Ability to oversee a program of studies
Assist the Manager and Sr. Director in defining and maintaining departmental standards, SOPs and working practices
Provide leadership, mentoring and statistical support for Biostatistics staff
Assist the Manager and Sr. Director in development of training materials and execution of training in Biostatistics and general Clinical Reporting activities, for new and existing Clinical Reporting staff
Make presentations to clients and other interested individuals about the processes and procedures of the Clinical Reporting department
Assist the Manager in the coordination of project tasks and resources across the Biostatistics group, and act as backup during the Manager’s absence, as assigned
Advanced knowledge of statistical methods used in the design and analysis of Phase I – IV clinical trials
Must be skilled in effective time management
Ability to communicate effectively, both verbally and in writing, with all levels of staff and with the public

231

Principal Biostatistician Resume Examples & Samples

Work with Clinical Science and Clinical Operations staff to develop scientifically sound clinical study designs and write the statistical section of clinical research protocols
Perform sample size calculations and simulations
Provide input to database requirements and SAS data set specifications
With the programmer, generate statistical summary tables, patient data listings and reports using SAS
Prepare statistical analysis plans
Perform statistical program validation and handle complex study programming issues
Contribute to the interpretation of clinical trial data and lead statistical methods and results section of the clinical study reports and scientific communications (presentations/manuscripts)
M.S. in Statistics, Biostatistics or related field
7+ years of experience in the design and analysis of clinical studies or 4+ years with a Ph.D. degree
Experience applying adaptive design and Bayesian methods to clinical trials
Experience in medical device, biotechnology or pharmaceutical industries
Proficient programming skills in SAS, R or SPlus; experience using SQL and EDC highly desirable
Knowledge of clinical trial methods and execution in a regulated environment
Strong interpersonal and customer-focused skills; exceptional ability to drive results through strong collaborating and influencing skills across all business segments and geographies
Demonstration or evidence of leadership competencies
Demonstration of strong oral and written communication skills, including experience presenting clinical trial results and statistical methods
Working knowledge and understanding of medical coding, including ICD, CPT, DRG, etc
Ability to provide leadership to colleagues and senior management in innovative statistical techniques

232

Biostatistician Resume Examples & Samples

Master’s degree in Biostatistics or a related field and two (2) years of experience in the job offered or closely related occupation
Employer will accept PhD and one year of experience in lieu of a Master’s degree and two (2) years of experience
Demonstrated experience with SAS programming; statistical theory; experimental design; categorical data analysis; analysis of variance (covariance); survival analysis; non-parametric methods; statistical design and analysis using ICH guidelines and programming techniques utilized in clinical research
15 % domestic travel is required

233

Biostatistician Resume Examples & Samples

Education - Bachelor's Degree or equivalent,Master's Degree or equivalent in Biostatistics, Statistics, or related field
Experience - 2 years of experience typically gained thru skills/knowledge/abilities in Managed care,Knowledge of computer information systems
Experience - Database or programming experience
Experience - Database or programming experience. Familiarity with Epic reporting tools and environments. Use of REDCap for data collection and management

234

Biostatistician Resume Examples & Samples

PhD in Biostatistics or related field
10+ years previous Biostatistician experience in data base management, advanced statistical analysis, presentation, spreadsheet, and word processing software
Advanced skills with statistical analysis software
Serve as a subject matter expert

235

Biostatistician Resume Examples & Samples

Provides statistically sound data collection, experimental design, and data analysis input to meet project objectives and, as applicable, FDA statistical requirements
Reviews study protocols, contributing to protocol statistical design and analysis sections,
Generates treatment allocation assignments
Develops and documents statistical analysis plans
Develops and executes statistical programs to perform analyses and prepare data displays
Generates ongoing study status monitoring reports including data monitoring committee reports and data displays for Investigational New Drug (IND) and Investigational Device Exemption (IDE) annual reports
Writes results sections of the clinical study reports
Supports publication of clinical trial results
Remains abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings
Masters’s degree in biostatistics, statistics, mathematics, statistical genetics, or related field or a Bachelor’s degree with at least 1 year of clinical trials experience
Excellent writing skills as evidenced by cover letter and writing samples

236

Biostatistician, Dppos Resume Examples & Samples

Prepares datasets for analysis, and conducts data analysis using advanced statistical procedures using SAS. Creates programming analysis related macros using SAS or R
Develops and maintains reporting systems using SAS
Performs data analysis using advanced statistical procedures using statistical software (SAS and R) under supervision of senior statisticians
Documents all new processes and procedures created in the above tasks
Collaborates in the design of studies and with medical investigators to implement methods in collaboration with Center faculty
Contributes portions of abstracts, posters, reports and manuscripts for major publications in leading health, medical and other journals and presentations of results
Performs data management (auditing, editing & analysis) and quality control of study databases
Participates in project development. Participate as a member of a multi-disciplinary team of programmers and researchers to ensure deliverables are completed efficiently
Experience in data management

237

Principal Biostatistician, Clinical Resume Examples & Samples

Bachelor’s degree with 7 years’ of experience in research or data analysis or Master’s degree with 5 years’ of experience in research or data analysis role, or Ph.D. degree with 2 years of experience in research or data analysis role
SAS and/or SAS programming experience
5 years working in medical devices, biotech/pharmaceutical Industry experience
Ability to make effective presentations
Ability to write speeches and articles using original or innovative techniques or style
Ability to work effectively independently and within teams
While performing the duties of this job, the employee is regularly required to be independently mobile

238

Senior Biostatistician Resume Examples & Samples

The Statistician will provide statistical and data-analytic support for the design and subsequent analyses of molecular and clinical data from design verification, analytical performance characterization and clinical validation studies in conjunction with registrational clinical trial assays (rCTA) and IVD CDx device development and registration
The candidate will work with cross functional teams of scientists, engineers, clinical and regulatory experts
Manage resources and priorities. Candidates with several years of experience will also be expected to help mentor junior team members
Establish and maintain excellent collaborative relationships with internal and external scientific groups involved in analysis
Establish and maintain sound working relationships and effective communication within Biomarkers and Diagnostics Biometrics (BDB) and BDM
Follow processes and adhere to our client's and project specific standards as well as Health Authority requirements (SOPs, BGs, Master Analysis Plan, GCP, and regulatory guidelines)

239

Senior Biostatistician Resume Examples & Samples

Provide timely and scientifically sound statistical expertise to clinical development projects
Interact with members of project teams, clinical scientists, clinical pharmacologist, statistical programmer and data management personnel to establish project timelines, data validation checks and perform statistical analyses
Responsible for providing statistical expertise in clinical study design. Collaborate in the preparation and review of protocols, CRF design and clinical study reports
Develop statistical analysis plans, perform exploratory data analysis as necessary and provide data interpretation
Manage CROs regarding statistical issues and activities to ensure timely delivery of analysis results. Provide guidelines and standards to CROs to ensure quality of deliverables
Collaborate with researchers and thought leaders in publication of study data
Keep abreast of new developments in statistics, drug development and regulatory guidance through literature review, conference attendance etc
Learn and expand existing knowledge of drug development regulations pertinent to statistical analysis
Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies
Internship experience, postdoctoral experience or experience while in graduate school may be considered as relevant
Candidate should also have interest in clinical drug development and knowledge of clinical trials design
Must have sound understanding of statistical application for clinical trials
Proficient in using statistical software (SAS, R, S+)
Excellent in both oral and written communications

240

Biostatistician Resume Examples & Samples

For grade 9E Bachelors Degree required and 1 or more years of work or internship experience
For grade 10EAdvanced Degree required and 2 - 3 years of work experience including post doc or research assistanceship
Working knowledge of Python, R, SQL, bash scripting, and the Linux operating system
Familiarity with R/Bioconductor packages for genomics and genetics analyses
Familiarity with bioinformatics resources (e.g. NCBI), genomics databases, and related tools and file formats
Expertise with exploratory data analysis and visualization methods, such as static plots (e.g. ggplot, matplotlib or seaborn), interactive plots and animations (e.g. d3js), and dashboards (e.g. Tableau or RShiny)
Expertise with the design and analysis of experiments, and with standard statistical approaches such as regression, linear and generalized linear models, and mixed models
Ability to work both independently and as a team member
Familiarity with Bayesian approaches, machine learning and text mining, and high-performance, distributed, and cloud computing preferred

241

Biostatistician Resume Examples & Samples

Masters degree in Biostatistics, Statistics or Biometry. (A Masters degree in Epidemiology, Health Services Research, Applied Mathematics or related field may be sufficient if all appropriate statistical coursework has been completed, or combination of extensive statistical training and experience.)
Experience implementing and familiarity with standard statistical techniques for clinical trials of diagnostic imaging, including testing for association, regression and survival analysis, basic study design, and methods for the analysis of diagnostic test accuracy studies. etc
Familiar with data maintenance and manipulation (variable creation, data checking, etc.)
Proven ability to work effectively on multiple projects at the same time and learn complex technical concepts
Proficiency in a major statistical software package (SAS, Stata or S-Plus). Experience computing in both a Windows and UNIX environment is also desirable
0-3 Years experience in Clinical Trials or Biomedical data analysis

242

Biostatistician Resume Examples & Samples

Ph.D. in Biostatistics preferred
Experience working with complex, large scale data sets, including data cleaning, security, selection of software, quality control, documentation and data reports
5 to 10 years of experience in managing, analyzing, and reporting on large datasets desired

243

Biostatistician Resume Examples & Samples

Consult with research investigators on research projects
Prepare data for analysis by selection of appropriate subjects and variables, merging data files, transformation of data, exclusion of outliers, etc
Perform statistical analyses to answer questions posed by investigators and in support of study grants
Prepare results for presentation in written or oral format
Participate in writing of manuscripts
Review literature and attend educational programs/seminars to keep abreast of current statistical techniques

244

Biostatistician Resume Examples & Samples

Masters degree in Biostatistics or related discipline and at least one year of related experience or equivalent in data analysis and data management
Must have excellent computer skills including experience with SAS, Stata, R, Excel, MS Word, Powerpoint, and the internet
Must be able to work independently, under minimal supervision and as part of a team

245

Biostatistician, Neurosurgery Days Msh Resume Examples & Samples

Identifies potential data problems from analytic queries and takes appropriate actions to guide the resolution process
Provides quality review on statistical analysis plan to ensure consistency with protocol and adequacy to meet objectives defined in protocol
Adheres to standard operating procedures of the functional department as they apply to documentation and validation of clinical research statistics
Provides consultation to the clinical research project team on statistical issues related to the project
1 year of biostatistics or related experience in clinical research preferred. Advanced level of experience in SAS, R or similar application

246

Biostatistician Resume Examples & Samples

Prepares statistical analysis plans, timelines for statistical project management and performs and interprets basic and complex analyses. Utilizes knowledge of statistics and medical understanding to propose and perform additional analyses when appropriate
Writes statistical text for study reports and clinical publications. Prepares analysis plans and methods used for incorporation in abstracts, manuscripts and grants
Collaborates with principal investigators, sponsors and external representatives to ensure that project results and conclusions are presented accurately and without bias and to jointly achieve objectives and timelines
Collaborates with statistical programmers that support clinical projects to identify potential data problems from analytic queries and to take appropriate action to guide the resolution process
1 year of biostatistics or related experience in clinical research preferred
Advanced level of experience in SAS, R or similar application

247

Senior Biostatistician Resume Examples & Samples

Ensures the statistical integrity and accuracy of all program and research data
Performs statistical design, modeling and analyses. Performs statistical programming to implement complex statistical analysis plans. Manipulates databases to obtain and analyze variables as required
Provides statistical summaries and reports of studies in support of product development
Interacts and consults with physicians, research scientists and other technical staff to ensure proper use of statistical methodology and interpretation of results
Programs statistical software packages (i.e., SAS, STATA, R software) to improve efficiency of life science projects
May respond to questions from regulatory authorities on statistical issues
Prepares statistical analysis plans, timelines for statistical project management and performs and interprets complex analyses. Utilizes knowledge of statistics and medical understanding to propose and perform additional analyses when appropriate
May develop and implement strategic, machine learning / biocomputational research investigational projects
May assist in the development of systems platforms within the department
Develops programmatic efforts to provide bio-statistical services to various clinical programs
Documents analyses, creates summaries and presents written and verbal results to requestors
Provides quality review on statistical analysis plans to ensure consistency with protocol and adequacy to meet objectives defined in protocol
Provides consultation to clinical research project teams on statistical issues related to the project
Master’s degree in biostatistics or related field (e.g., epidemiology). PhD degree preferred
5 years of biostatistics or related experience in a medical or healthcare setting. Two years working with large and complicated data sets (e.g., claims-type data/healthcare administrative databases)
MS Word and Excel – Advanced
SAS (preferred) or similar application (R/STATA) – Advanced
SAS (or other) SQL experience preferred

248

Biostatistician Resume Examples & Samples

Design of large observational studies based on institutional EPIC electronic health record and national administrative medical databases
Data management and statistical programming
Conducting data analysis and report writing under the mentorship of senior staff
Decision and cost-effectiveness analysis. The candidate will receive additional training in decision analytic methods including cost-effectiveness analysis of alternative health care interventions, and meta-analysis
Two or more years of experience as a statistical programmer or analyst
As the I-HDS has a strong interest in computer simulation studies of health care interventions, experience with stochastic simulation models is desirable
Previous collaborative research experience with health care related data is a plus
Master’s degree in Biostatistics or a related discipline (such as computer science, mathematics, econometrics, engineering, physical sciences)
Experience with regression and survival analysis
Excellent computer skills are required including experience with programming in SAS, Stata, SPSS, S-Plus, and/or R
Proficiency with Microsoft (Word, Excel, PowerPoint)
Candidates must have excellent written and communication skills in English and must be able to work independently, under minimal supervision, and as part of a team

249

Biostatistician Resume Examples & Samples

Assist with the design of observational and randomized clinical trials
Collaborate with the faculty, fellows and residents in the department of Otolaryngology-Head and Neck Surgery
Assist with data tabulation and preparation of reports, analysis of data

250

Biostatistician Resume Examples & Samples

The Department of Bioinformatics is seeking a highly motivated bioinformatics data analyst to perform bioinformatic data analysis and application development
The successful candidate will have the opportunity to work in a fast-paced and highly collaborative environment to support clinical development programs with a focus on analyzing NGS sequencing data and contributing to web application development
Analyze large-scale genomic data, such as next-generation sequencing (Exome, Whole genome and RNA-seq) data from patient samples to support patient stratification and biomarker selection for multiple development programs
Develop bioinformatic software, analysis pipelines and applications to make genomics results and findings available to research and development colleagues
A master (or bachelor with substantial experience) in bioinformatics, computational biology, genomics, computer science, statistics or a related field
Familiar with Linux working environment and high performance computing
Experience in web/database development is a plus
Outstanding team player with strong interpersonal and communication skills

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