Biostatistician Senior Resume Samples

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W Aufderhar

Wendy

Aufderhar

5300 Greenfelder Court

Chicago

+1 (555) 900 3911

5300 Greenfelder Court

Chicago

Phone

p +1 (555) 900 3911

Experience Experience

Chicago, IL

Senior Research Biostatistician

Chicago, IL

Corkery, Dibbert and Stiedemann

Chicago, IL

Senior Research Biostatistician

Provide mentorship of junior staff to advance scientific stature and professional development
Provide statistical support and leadership to epidemiological studies
Plan/direct the preparation of proposals of significant technical or organizational complexity, contract value, or strategic importance
Contribute to scientific stature by publishing in peer reviewed journals and presenting at professional meetings
Analyze results, synthesize findings in context of existing knowledge, author study reports and manuscripts
Define, investigate, and formulate approaches and solutions to the most complex problems faced by the organization and its clients, within broadly defined policies, guidelines, practices, and concepts
Lead epidemiology research studies, surveillance studies, and/or investigations of new drugs and treatments such as observational safety studies of products or procedures (as project director, associate project director or principal investigator). Provide fiscal oversight to project (especially contract) budgets

San Francisco, CA

Senior Principal Biostatistician

San Francisco, CA

Koss Group

San Francisco, CA

Senior Principal Biostatistician

Good business ethics
Provides strategic input to the target patient value profile (TPP) and the clinical development plan including regulatory submission strategy and the life cycle of a development compound
Lead the development, assessment and introduction of new statistical technology and methodology, including statistical model-based drug development approaches using frequentist and/or Bayesian methodologies
Provides statistical and strategic input in the writing of Statistical Analysis Plans (SAPs) and Integrated SAPs, and for pooling strategies for regulatory submissions
Stays current with ongoing developments in statistical methods applications in the pharmaceutical industry, both pre- and post-registration
Act as the biostatistics lead for scientific evaluation of in-licensing opportunities
Provides statistical sciences training to UCB employees from different disciplines on advanced statistical concepts

present

Los Angeles, CA

Principal / Senior Principal Biostatistician

Los Angeles, CA

Feest and Sons

present

Los Angeles, CA

Principal / Senior Principal Biostatistician

present

Develop and assist in maintenance of department tools, templates, guidelines, SOPs, and systems
Provide update on program progress with focus on biometrics to management
Design and write statistical analysis plans for clinical trials or oversee this work
Knowledge of FDA regulations, ICH GCP guidelines, the drug development process
Collaborate with Medical Directors and other study personnel on the creation of clinical development plans and clinical trial designs
Provide leadership to the biometrics team (data management, programming, statistics) on a given clinical program, group of programs, or key study(ies); review work of statisticians supporting this work
Write statistical sections of regulatory submissions or oversee this work

Education Education

Master’s Degree in Biostatistics

Kaplan University

Master’s Degree in Biostatistics

Skills Skills

Solid knowledge of statistical analysis methodologies and experimental design
Solid knowledge of statistical applications in pharmacoloepidemiology and safety evaluations
Good project management and matrix leadership skills. Ability to collaborate well with non-statistical functions
Solid record of leadership in professional society activities
Solid knowledge of statistical and data processing software e.g. SAS and/or R
Excellent oral and written communication skills and strong leadership in a team environment
Strong scientific leadership in design and analysis of clinical trials
Demonstrated ability in statistical research activities and in application of novel methods to clinical trial development
Good business ethics
Solid publication record in peer reviewed statistical/epidemiological/medical journals

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15 Biostatistician Senior resume templates

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Senior Principal Biostatistician Resume Examples & Samples

Excellent analytical skills, with the ability to process scientific and medical data
Excellent knowledge of statistical programming
Expertise in manipulating and analyzing SAS data
Ability to identify data issues, present problems, and implement solutions
Capability of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues
Good leadership, organizational and time management skills, with the ability to multi-task
Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)
Strong interpersonal communication and presentation skills
Ability to effectively collaborative across cross-functional teams
Act as the lead statistician on clinical research projects
Provide statistical expertise for study design of clinical trial protocols
Write statistical methods section of the study protocol, as needed
Write statistical analysis plans ensuring appropriate regulatory requirements and study objectives defined in the study protocol are followed
Review CRFs to ensure consistency with protocol and adequacy in collecting data to meet objectives and statistical analyses defined in the protocol
Program summary tables, data listings and graphical representations of clinical trials data
Perform all analyses defined in the statistical analysis plan as well as any post-hoc analyses and relevant exploratory analyses of clinical trial data
Prepare key sections of clinical study reports and various regulatory documents
Perform statistical QC of final clinical study reports
Provide statistical support to answer questions from external clients (such as FDA, Investigators)
Contribute to the development of standard operating procedures for clinical trials
Represent statistical operations department at regulatory meetings, sponsor meetings, and any other multifunctional meetings, as needed
Adhere to all aspects of the Client's quality system
Comply with Client's data integrity & business ethics requirements

Senior Clinical Biostatistician Resume Examples & Samples

Lead and / or assist in the development and maintenance of analytic projects and reporting to support the business
Anticipate, design, and measure solutions to facilitate the business and clinical needs of the organization including qualitative and quantitative reporting and analysis
Support for prospective client analysis and reporting including formulary analysis, plan design analysis, forecasting, and clinical program savings evaluation
Maintain and refine existing reports, analytical models, and database queries as appropriate
Validation of source data and interpretation of report results
Interface with IT Department regarding business needs
4+ years’ experience with MS Office
Strong commitment to customer service and ability to work collaboratively across multi-disciplinary teams
3+ years of working with large complex databases
3+ years of healthcare work experience
1+ years of SAS programming experience
2+ years hands-on experience with SQL queries
Master’s degree
Experience with Python and R
SharePoint experience a plus
Experience in medical or pharmacy claim data analysis is desired, although not required
Experience documenting business requirements for complex projects

Senior / Principal Biostatistician Resume Examples & Samples

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
Helps manage clinical trials efficiently by providing accurate and consistent information to both sponsors and Company business/functional units
Strong project leadership experience

SAS Biostatistician / Senior Biostatistician Resume Examples & Samples

Exercise initiative in handling complex special projects for which routine solutions are not available
Compose the required documentation (including scope of work, statistical memos and reports) for reporting statistical data, analysis and conclusions for internal and external meetings and conferences
Provide and organize statistical support for regulatory meetings, questions from the regulatory authorities and related major stage gate regulatory submissions
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
Establish statistically valid and efficient experimental statistical plan statistical protocols for assay development and assay validation related experiments
Perform hands-on data analysis and modeling of obtained data to provide outputs that will guide in decision making through various stages of project. This includes but is not limited to Pharmacokinetic, Immunogenicity and Biomarker assays, sensitivity, specificity, assay drifts, Variability analyses between lots of reagents, preclinical and clinical sample distribution analysis
Mentor other scientists in the Bioanalytical team on statistical concepts and software data analysis
Coordinate tasks as needed with other BAS group members and other line functions ensuring timeliness and adequate quality of statistical deliverables
Provide assistance in the data representation and interpretation required for team publications (Internal & External)
Follow Regeneron processes and adhere to project standards as well as specific Health Authority requirements

Senior Biostatistician / Biostat Resume Examples & Samples

Advise data management staff on database design, and critical data. May advise on validation checks
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
Assist with review of RFPs and QIPs; prepare proposal text. May participate in bid defense meetings
PhD in biostatistics or related field; Master's degree in biostatistics or related field and 1 year relevant experience; Bachelor's degree or educational equivalent in biostatistics or related field and 3 years’ relevant experience; or equivalent combination of education, training and experience
Excellent attention and accuracy with details
In-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Familiarity with moderately complex statistical methods that apply to applicable clinical trials
Familiarity with other relevant statistical computing packages such as StatXact
Strong commitment to quality

Senior Biostatistician Nationwide Homebased Resume Examples & Samples

Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage scope, and provide revenue and resource forecasts for single studies. May manage project budget and resource requirements
Masters degree or educational equivalent in computer science or related field and 3 years relevant experience; Bachelor's degree or educational equivalent in computer science or related field and 4 years relevant experience; or equivalent combination of education, training and experience
Knowledge of statistics and/or clinical drug development process
Familiarity with SAS Drug Development (SDD) and Clinical Data Integration (CDI) would be preferred
Phase 4 experience preferred
Experience with writing or reviewing SAPs and working with programmers and Clinical to plan and deliver ad hoc analyses
Ability to accurately interpret the analysis and highlight the limitations
Strong SAS (hands on) experience, knowledge of other software e.g,, R etc. are encouraged
Ability to address and manage multiple priorities, strong in written and oral communication skills

GFR Senior Biostatistician / Biostatistician Resume Examples & Samples

Strong individual initiative
Ability to provide and accept direction of lead team members
PhD in biostatistics or related field; Master's degree in biostatistics or related field and 1 year relevant experience; Bachelor's degree in biostatistics or related field and 2 years relevant experience; or equivalent combination of education, training and experience

Biostatistician Senior Resume Examples & Samples

Provide subject matter expertise and guidance to various departments and functional areas including Quality, MSAT,Technical Support, and Validation
Work with Corporate Statistics group to ensure all statistical methods comply with regulations, guidance and standards published by FDA, ICH, EMA and other regulatory groups in project area
Provide on-site statistical training as required
Co-author, review and/or approve SOPs, protocols and reports containing significant statistical content with minimum supervision
Perform process and data analysis for annual product reviews (APR) and periodic SPC reviews and support process investigations
Maintain and demonstrate knowledge of state-of-the-art statistical practices and theories, and adopt them for successful completion of projects
Provide technical leadership in tasks that include DOE, analysis of data, statistical process control (SPC), Quality by Design (QbD), simulation, design of sampling plans, and problem solving
Develop and implement process monitoring tools
Provide guidance to less experienced staff as needed

Senior Biostatistician / Biostatistician Home Resume Examples & Samples

Act as statistical team lead for single complex studies or groups of studies
Masters degree or educational equivalent in computer science or related field and 3 years relevant experience; PhD and 2-3 years relevant experience or equivalent combination of education, training and experience
Knowledge of statistical computing applications such as Base SAS, SAS/STAT and SAS Macro Language

Senior Principal Biostatistician Resume Examples & Samples

Solid knowledge of statistical applications in pharmacoloepidemiology and safety evaluations
Solid publication record in peer reviewed statistical/epidemiological/medical journals
Strong scientific leadership in design and analysis of clinical trials
Demonstrated ability in statistical research activities and in application of novel methods to clinical trial development
An understanding of biology of disease and drug discovery and development

Biostatistician, Senior Resume Examples & Samples

Interacts with development and clinical investigators to design clinical trials with appropriate statistical methods and adequate sample size for statistical justification of clinical utility claims
Writes data analysis plans as needed to capture design elements and statistical methodology
Develops data entry spreadsheets as needed
Troubleshoots and improves current statistical designs, including those developed elsewhere in the organization
Maintains expertise in state-of-the-art data manipulation and statistical analyses, and mentors less experienced colleagues
Manages day-to-day operational aspects of a project

Director, Senior Principal Biostatistician Resume Examples & Samples

Lead the development, assessment and introduction of new statistical technology and methodology, including statistical model-based drug development approaches using frequentist and/or Bayesian methodologies
Performs as a highly competent and experienced senior level biostatistician by functioning as a technical resource and internal statistical consultant across therapy areas, and as a coach/mentor to GSS staff
Serves as a sitting statistical consultant on the UCB Science to Solutions Table, giving critical and constructive input into study designs
Provides statistical and strategic input in the writing of Statistical Analysis Plans (SAPs) and Integrated SAPs, and for pooling strategies for regulatory submissions
Effectively lead cross-functional or multi-disciplinary groups and use technical expertise to pro-actively influence business decisions
May be asked to participate on special projects across therapy areas. Such other responsibilities and projects that the Company may assign
Familiarity with later Phase studies, eg, non-interventional, retrospective studies, or experience working with Health Technology Assessment (HTA) bodies
Able to serve as a senior statistical and pharmaceutical consultant for biostatisticians in GSS and across therapy areas
Able to conduct independent statistical research
Sound knowledge of the ICH guidelines. Understanding of the regulatory requirements from main health authorities (eg, EMA, FDA and PMDA), and of the submission process in each
Vast experience with regulatory submissions to various health authorities and HTA bodies
Excellent project management skills
Able to provide training of advanced statistical topics to biostatisticians in GSS and able to explain advanced statistics in a non-technical manner to non-statisticians
Able to travel both domestically and internationally as business necessitates
Able to multi-task and to project future statistical needs; has the maturity to work in a highly independent, self-motivated manner
Is a keen learner. Shows an active participation toward learning new statistical concepts and the relevant aspects of the disease area of the related programs
Able to work in a multicultural global environment
Able to adapt to changing priorities and deliver results in a timely manner

Senior.biostatistician Resume Examples & Samples

Develop analysis plans, table shells, programming and table specifications; produce tables, listings and figures; perform data review and statistical analysis
Assist with protocol development, sample size calculation, and protocol and case report form (CRF) review
Assist in writing statistical sections of integrated reports
Strong aptitude for, and working knowledge of SAS computing package

Principal / Senior Principal Biostatistician Resume Examples & Samples

Provide leadership to the biometrics team (data management, programming, statistics) on a given clinical program, group of programs, or key study(ies); review work of statisticians supporting this work
Provide update on program progress with focus on biometrics to management
Collaborate with Medical Directors and other study personnel on the creation of clinical development plans and clinical trial designs
Perform or oversee performance of power/sample size calculations to determine appropriate trial size; run simulations to assess operating characteristics of designs
Provide statistically sound experimental design and data analysis input to meet project objectives and regulatory (e.g. FDA) requirements
Design and write statistical sections for clinical trial protocols or oversee this work
Generate study randomizations and provide input on maintaining study blinding
Design and write statistical analysis plans for clinical trials or oversee this work
Write statistical sections of regulatory submissions or oversee this work
Design and conduct statistical analysis of clinical data or oversee this work
Work with medical monitors to develop ad hoc analysis plans and perform analyses or ensure analyses are performed appropriately by programming staff
Represent Seattle Genetics statistical position to regulatory agencies
Key contributor in project planning (timelines, etc.) with clinical, regulatory and data management
Keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings
Become knowledgeable in disease areas under study (e.g. available treatments, course of disease, endpoints, analyses used for previous submissions)
Develop and assist in maintenance of department tools, templates, guidelines, SOPs, and systems
Knowledge of FDA regulations, ICH GCP guidelines, the drug development process
Principal: MS with 6+ yrs or PhD with 4+ yrs/study stat with high independency for complicated studies
Sr. Principal: MS with 8+yrs or PhD with 6+ yrs/ Program Lead Stat for early programs or pivotal studies for late programs
Previous experience providing leadership to biometrics staff within a clinical team
Knowledge and experience to exercise independent judgment and provide indirect oversight to programmers, data managers, and more junior statisticians
Excellent communication and presentation skills, both written and verbal
Sound understanding of ICH guidelines and FDA requirements
Proficiency with SAS® procedures and programming language

Senior Research Biostatistician Resume Examples & Samples

A minimum of a PhD with 1 year post doc of statistical analysis experience is required
A minimum of 3 years in a medically-related position that includes FDA, GCP or relevant area is also required
Expertise in statistical methodologies in preclinical, clinical, and non-clinical settings is required
Experience with survival analysis, optimal experimental design, Bayesian methods and adaptive designs is strongly preferred
Knowledge of products/therapeutic areas being evaluated including at least one of the following: orthopedics, gynecology, cardiovascular or general surgery is preferred
Experience working with SAS and R is required
Job requires travel, up to 15%Biostatistics

Senior Biostatistician, Work From Home Resume Examples & Samples

Hands-on experience and knowledge with SAS and other statistical software
Good knowledge in applied statistics including study design methodologies, categorical data analysis, survival analysis etc. Exposure to the use of modeling and simulation to enhance clinical trial design and decision making would be advantageous
Good understanding of clinical research and drug development process, and requirements on regulatory submissions and compliance
Familiar with ICH guidelines, regulatory requirements and industry standards (eg CDISC) and awareness of best practices related to statistical and programming activities
Good teamwork skills placing emphasis on supporting the goals of the group
Excellent time/project management and problem solving skills
Ability to manage multiple protocols and participate in multiple clinical project teams simultaneously
Absolute integrity, honesty, reliability and passion / enthusiasm about advancing therapies for patients
Trustworthy and respectful
Passion for results
At least 5 years of biostatistics in a regulated clinical research environment (pharmaceutical / biotechnology / CRO) required
Ability to program in SAS
Experience leading statistical activities in clinical research
Knowledge of basic statistical design, analysis, ICH guidelines and programming techniques utilized in clinical research

Senior Biostatistician / Oncology Resume Examples & Samples

Designs and analyzes oncology clinical trials; hospital and/or large national databases; high dimensional xomics studies
Collaborates with LCI investigators and other biostatisticians on the development of statistical designs and statistical analysis plans for oncology clinical trials
Leads efforts regarding sample size calculations, generation of randomization schemes, and development of statistical methodology sections for protocols and analysis plans
Develops programs to execute statistical analyses of data from research studies conducted throughout the Cancer Institute
Collaborates with study teams in support of development of manuscripts, abstracts, posters, presentations, and other data disclosures
Collaborates on the design, implementation, and maintenance of analysis data sets and other integrated databases
Provides statistical collaborations in support of mining and querying of LCI and System wide databases

Senior Associate Biostatistician x Resume Examples & Samples

Provide statistical insight and contributions to the study teams
Provide statistical review and quality control of protocols, randomization specifications, Statistical Analysis Plans, analysis specifications and Clinical Study Reports
Complete statistical analysis of individual studies/projects
Publish applied research in scientific journals, and give presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings
Represent Biostatistics in the Clinical Study Teams
Participate in global product team meetings
Experience of working in a busy department within the biopharmaceutical industry
An understanding of the processes involved in drug development and knowledge of working with clinical trial data
Experience in the use of Statistics and SAS programming (including extensive training)
Experience of manipulating, summarising and reporting clinical trial data
Insight into other departments within Amgen and how they interact
Experience of working in teams with other Statisticians and Programmers
A degree (or higher qualification in mathematics, statistics or a related discipline)
Good communication and organisational skills and be motivated by working to deadlines
An ability to work in teams and remain flexible to changing priorities
An understanding of some areas of the life sciences/medicine and willingness to learn new areas
A keen interest in statistics and its application

Senior Principal Biostatistician Resume Examples & Samples

Influences decisions that directly impact the trial/project and team ability to deliver objectives
Experience in all tasks of a statistician at the trial/experiment level and demonstrated independence in the role. Proven knowledge and expertise in statistics and its application to clinical trials; able to explain statistical designs and concepts. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Proficiency in use of statistical software packages (e.g. SAS, R). Good knowledge of drug development and Health Authority guidelines. Demonstrated effectiveness working on a multidisciplinary team to achieve team objectives
Good understanding of Franchise/Therapeutic Area and or regulatory activities
Good project management and matrix leadership skills. Ability to collaborate well with non-statistical functions
Good business ethics

Senior Principal Biostatistician Resume Examples & Samples

Provides strategic input to the target patient value profile (TPP) and the clinical development plan including regulatory submission strategy and the life cycle of a development compound
As needed, carries out advanced statistical analyses to address complex design problems across therapy areas, for instance, performing complex simulations to determine sample size and power considerations for different study design options
Stays current with ongoing developments in statistical methods applications in the pharmaceutical industry, both pre- and post-registration
Provides statistical sciences training to UCB employees from different disciplines on advanced statistical concepts
Seeks opportunity to represent UCB by active participation in external professional/technical forums
As needed, assumes the full responsibilities of a Principal Biostatistician in support of a therapy area mission
Reviews and approves abstracts, posters, presentations, and manuscripts for publication and ensures accuracy of all biostatistical aspects of such documents
10+ (with Ph.D.) to 13+ (with Master degree) years in biostatistics within the biotechnology and/or pharmaceutical industry (including CROs) with a proven successful track record in pharmaceutical development and statistical methodology
Sound knowledge of the implications of the pharmacokinetic profile of a drug on the design of pharmacodynamics and Phase I-III studies, or vice versa
Strong experience with advanced statistical methodologies
Good knowledge of SAS and/or R programming
Excellent knowledge in visualization and simulation techniques
Excellent written and verbal communication skills in English
Able to work under pressure and without supervision
Able to adapt to change
Able to communicate clear, precise, accurate instructions and to interact effectively in a consulting environment
Able to pro-actively propose and defend alternative innovative study designs and statistical methods that will help accelerate the development process or market access

Senior Principal Biostatistician Resume Examples & Samples

Ten years of postgraduate experience in the application of statistics to clinical trials, preferably with at least one year of statistical project responsibility with a CRO
Cooperative, team-oriented and proactive
Ability to motivate others
Ability to adhere to strict guidelines and codes of practice
A good knowledge of the overall Clinical Trial process and of its application within Covance Clinical Development
Competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc., across a variety of trials
Ability to explain statistical concepts to non-statisticians
Supervisory and organizational skills
A proactive approach to management of day-to-day activities and actions that may affect Covance as a business
A professional approach at all times

Senior Principal Biostatistician Resume Examples & Samples

Bachelors Degree in related field, or equivalent work experience
4+ years experience in related field preferred
Advanced Degree in related field preferred
Participates in the development of policies and procedures to achieve specific goals
Works on or may lead complex projects of large scope
Projects may have significant and long-term impact
Receives guidance on overall project objectives
Acts as a mentor to less experienced colleagues

Senior Principal Biostatistician Resume Examples & Samples

Take on the key statistical responsibility in the planning and preparation of regulatory submissions as required. Lead other statisticians within a project. Represent the company before outside agencies on statistical issues
Advise on the design of valid, efficient and cost effective clinical trials and other research projects. Prepare statistical methodology sections for protocols and Trial Statistical Analysis Plans (TSAPs). Exercise initiative in handling complex special projects for which routine solutions are not available
Support management in resource planning and tracking for assigned trials and projects
Act as a team leader for a complex project or mega-trial who
Works directly and proactively with the Trial, Project or Substance team
Oversees and delegates statistical tasks to other team members

Senior Principal Biostatistician Resume Examples & Samples

Represent PAREXEL Biostatistics at client meetings (such as Joint Operations Committee, forums or other similar venues where applicable)
Point of contact for clients and within PAREXEL for matters related to project deliverables
Interact with clients and regulatory authorities
Extensive clinical trial statistical knowledge and through understanding of statistical issues
Ability to clearly describe advanced statistical techniques and interpret results
Experience with CDISC (SDTM, ADaM)
Excellent client relations skills
PhD in Statistics or related discipline with 3+year experience or MS in Statistics or related discipline with 10+ years of experience
Submissions experience would be a plus
Industry experience; Biopharmaceutical or CRO

Senior Research Biostatistician Resume Examples & Samples

Provide statistical support and leadership to epidemiological studies
Define, investigate, and formulate approaches and solutions to the most complex problems faced by the organization and its clients, within broadly defined policies, guidelines, practices, and concepts
Analyze results, synthesize findings in context of existing knowledge, author study reports and manuscripts
Contribute to scientific stature by publishing in peer reviewed journals and presenting at professional meetings
Plan/direct the preparation of proposals of significant technical or organizational complexity, contract value, or strategic importance
Doctorate in statistics, biostatistics, mathematics, or related public health field and 8 years of related experience
Evidence of ability to win, manage, and monitor government contracts, grants and/or cooperative agreements
Leadership and management excellence. Ability to motivate a team and work well with others. 
Experience with government contracting. 
Attention to detail and accuracy.