Statistical Scientist Resume Samples

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NW
N Wolff
Noah
Wolff
42687 Madisen Fall
Detroit
MI
+1 (555) 534 0415
42687 Madisen Fall
Detroit
MI
Phone
p +1 (555) 534 0415
Experience Experience
New York, NY
Statistical Scientist
New York, NY
Parisian Group
New York, NY
Statistical Scientist
  • To assist in Product & Test Method development/improvement projects
  • Provides analytical and strategic leadership for exploratory activities such as personalized healthcare biomarker development and PK/PD modelling
  • Manage customer relationships and provide training and guidance to lower level and new staff
  • Collaborates and consults with biomarker scientists in support of clinical development projects and presentations/publications and perform potentially complex biomarker analyses in support of these efforts
  • As part of clinical teams, collaborates in the design, planning, conduct, reporting and regulatory submissions of clinical studies to meet project objectives, including exploratory project activities such as biomarkers and PK/PD analysis
  • Provide statistical and strategic leadership for clinical development projects and exploratory biomarker analysis activities
  • To design and manage process/test method improvement projects and validations
Houston, TX
Associate Statistical Scientist
Houston, TX
Wehner, Schowalter and Cormier
Houston, TX
Associate Statistical Scientist
  • Contributes to the biostatistics/scientific community by actively serving as subject matter expert and participating in internal/external initiatives
  • Study Planning: With assistance of senior statistical scientists, reviews study protocols, authors statistical sections of protocols, develops independent data monitoring and endpoint committee charters
  • Develops the statistical and data analysis plans, and prepares the study randomization
  • Study Conduct: Reviews case report forms to ensure protocol objectives are met and project standards are maintained. Develops statistical programs as necessary to perform analyses, Review and approve analyses produced by statistical programming, ensuring the accuracy and validity of results
  • Analysis & Reporting: Author the clinical study report, and with assistance of senior scientists and cross-functional team members provides input into global health authority documents and regulatory response for health authority submissions
  • Contributes to study publications and presentations, and provides analytical support for exploratory activities such as personalized healthcare biomarker development and PK/PD modelling
  • Keeps abreast of new developments in statistics, drug development, biomarker development, and regulatory guidance through literature review, conference attendance, and other scientific forums
present
Phoenix, AZ
Senior Statistical Scientist
Phoenix, AZ
Hintz-Turcotte
present
Phoenix, AZ
Senior Statistical Scientist
present
  • Perform, advise, and review protocol development, sample size calculation, protocol and CRF review
  • Provide training, guidance and mentorship to lower level and new staff
  • Build collaborative networks within Monsanto and outside of Monsanto
  • Develop predictive models using agronomic, geospatial or other high-dimensional data
  • Develop as a primary contact as an expert in at least one therapeutic area including knowledge of therapeutic guidelines
  • Collaborate with multi-disciplinary teams to optimize discovery and development strategies
  • Lead initiatives to identify and implement process improvements
Education Education
Bachelor’s Degree in Biostatistics
Bachelor’s Degree in Biostatistics
West Virginia University
Bachelor’s Degree in Biostatistics
Skills Skills
  • Strong computational background (e.g. programming in R, Python, Clojure, MATLAB and or SAS) and skills in data mining and predictive analytics methodologies
  • Keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review, conference attendance, etc
  • Experience on conducting (multi-environment, agricultural) field research and analyzing data
  • Strong people and communication skills: demonstrated to be a great team player. Ability to influence key stakeholders, work and communicate effectively with a diverse group with scientists and non-scientists to accomplish goals
  • Two to three years of experience in data analysis, consulting and problem solving in an agronomic or breeding environment
  • M.S. with five years of experience, or Ph.D. in Statistics, Biometrics, Plant Science or related field
  • Experience in presenting, teaching and engaging with partners to align and execute on best practice to obtain superior results
  • Successfully represent biostatistics/other biometrics functions on development teams
  • Provide statistical and strategic leadership for clinical development projects,
  • Directly responsible for the statistical integrity, adequacy, and accuracy of the clinical studies within the project, including activities to support personalized healthcare strategy
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11 Statistical Scientist resume templates

1

Associate Director Statistical Scientist Resume Examples & Samples

  • Drive and steer the strategic quantitative framework for (pre/early/full-) clinical programs in close collaboration with (early) project teams
  • Represents the GPT internally and externally as the statistical scientist with leading quantitative skills, including regulatory interfaces, with objective and transparent program quantitative risk/probability of success assessments
  • Leads statistical scientific evaluation of in-licensing opportunities
  • Represents IIS at project level internal/external meetings with respect to statistical scientific input and in portfolio level governance boards (e.g TM forum, IFB)
  • Interacts with Health Authorities and external key opinion leaders as the recognized Novartis expert at the program (or equivalent) level for all quantitative aspects of the program. Represents IIS at across global regulatory hearings/advisory committee meetings and other global regulatory interfaces
  • Provides biostatistics and drug development expertise to infrastructure and process improvement initiatives; may lead such initiatives
  • Provides technical statistical expertise and leadership and serves as a role model for innovation on behalf of IIS
  • Serves as mentor, and may undertake role of development/appraisal coordinator for selected IIS Franchise associates
  • May act as CSU statistical scientist
  • Application of high quality methodology across the multiple indications/therapeutic area: cutting edge statistical methodology, innovative designs, creative project plan solutions, integrated proficient disease area understanding, and health authority acceptability
  • Strong IIS team dynamics to support robust (pre/early/full-) Clinical Program as assessed by team colleagues
  • Effective coaching and development of statistical scientists and biometricians, as assessed by the IIS Program Head
  • 4+ years influencing (pre/early/full-) clinical development programs establishing, and regulatory approvals with global leadership of the statistical sciences within the development plans, within at least one indication/disease area. Strong disease area and guidelines knowledge
  • Contributes to external white-papers/policy shaping best practice statistical science. Has strong and established track record of developing/establishing statistical excellence. Established experience in leading global scientific improvement/change initiatives
  • Strong interpersonal and communication skills ( verbal and writing) bridging scientific and business needs – integrating quantitative sciences, strong disease area knowledge and appropriate market/competitive intelligence
  • Natural modern leadership style building partnerships and collaborative environments
2

Senior Principal Statistical Scientist Resume Examples & Samples

  • Drive and steer the strategic quantitative framework for the suite of clinical trials in close collaboration with (early) project teams
  • Represents the GPT/GCT/CTT (or equivalent) internally and externally as the statistical scientist with leading quantitative skills, including regulatory interfaces, with objective and transparent clinical trial quantitative risk/probability of success assessments
  • In collaboration with clinical counterparts (Global Brand/Project Medical Directors/ Translational Medicine Experts) and Global Project Teams/GCT/CTTs, influence and negotiate clinical trial designs aligned with the CDPs/TPPs. Leads the quantitative evaluation of competing trial/analysis strategies assuring robust support to clinical development planning and execution. Contributes to the clinical development plan of the project or indication Contributes to the statistical strategic and quantitative contributions to regulatory/submission strategy and related documents (e.g.: Target Product Profile, sPOC document, CDP, Briefing Books, Risk Management Plan and responds to HA questions)
  • Across the multiple trials within the project or indication (or equivalent), is responsible for the full integration of modern aspects of drug development including model-based drug development and statistical methodologies in collaboration with partners
  • Contributes to the statistical scientific requirements, synthesis and integration of information to support transition of drug development milestones / decision boards
  • Contributes to ongoing data exploration of trials pre- and post-database lock data, of related trial data, of relevant available external data, with a sense of urgency and pragmatism, to address risks on patient safety and trial quality, to understand trial results and put them in a broader perspective, to prepare trial reporting, submission planning and health authority interactions
  • May lead statistical scientific evaluation of in-licensing opportunities
  • Represents IIS at project or indication level internal/external meetings for strategic statistical scientific inputs
  • Identifies opportunity and integrates Statistical Methodology where necessary, make sure
3

Associate Director Statistical Scientist Early Development Resume Examples & Samples

  • Drive and steer the strategic quantitative framework for (pre/early) clinical programs in close collaboration with (early) project teams
  • Represents the Global Program Team internally and externally as the statistical scientist with leading quantitative skills, including regulatory interfaces, with objective and transparent program quantitative risk/probability of success assessments
  • In collaboration with clinical counterparts (Global Brand/Project Medical Directors/ Translational Medicine Experts) and Global Project Teams, influence and negotiate clinical development plans (CDPs/TPPs). Leads the quantitative evaluation of competing program/trial/analysis strategies assuring robust clinical development planning and execution
  • Defines and drives statistical strategic and quantitative contributions to regulatory/submission strategy and related documents (e.g.: Target Product Profile, sPOC document, CDP, Briefing Books, Risk Management Plan and responds to HA questions), Drives the full integration of modern aspects of drug development including model-based drug development and statistical methodologies in collaboration with partners, facilitates and manages internal and external stakeholders through to PoC/DDP or regulatory acceptance
  • Drives and coordinates the synthesis and integration of information to support transition of drug development milestones / decision boards. Identifies alternative strategic options to risk mitigate programs – thus limiting potential negative impact on (pre/early/full-) program success
  • Represents Core Analytics at project level internal/external meetings with respect to statistical scientific input and in portfolio level governance boards (e.g TM forum, IFB)
  • Ensure full integration of Statistical Methodology, make sure that the IIS team (biometrician, data management, database programming, statistical programming, medical and scientific writing are aligned
  • Provides technical statistical expertise and leadership and serves as a role model for innovation on behalf of Core Analytics
  • Serves as mentor, and may undertake role of development/appraisal coordinator for selected Biostatistics Franchise associates
  • Quality and timely implementation of robust, high quality (pre/early/full-) clinical development strategies (program/trial/analysis strategies) including quality lead contribution at scientific and regulatory meetings, as assessed by the respective (pre/early/full-) Clinical Program lead and/or by the Biostatistics Program Head
  • Pro-active and role-model disease area level presentation of statistics in the Project Teams/Global Program Team , as assessed by the respective (pre/early/full-) Clinical Program lead and/or by the Biostatistics Program Head
  • Strong team dynamics to support robust (pre/early) Clinical Program as assessed by team colleagues
  • Effective coaching and development of statistical scientists and biometricians, as assessed by the Biostatistics Program Head
  • Expert scientific leadership skills demonstrated in facilitating and optimizing the (pre/early/full-) clinical development strategy. Strong track record for global scientific leadership in the development and evaluation of modern program/trial design methodologies
  • Expert skills to facilitate and maximize the contribution of quantitative team
  • Hands-on experience in leading the interface to regulatory agencies/leading the early clinical development campaign
4

Statistical Scientist Resume Examples & Samples

  • M.S. with five years of experience, or Ph.D. in Statistics, Biometrics, Plant Science or related field
  • Expertise in wide range of statistical techniques including, but not limited to experimental design, (non-) linear mixed models, multivariate statistics, non-parametric analysis, BLUP methodology and Bayesian statistics
  • Experience on conducting (multi-environment, agricultural) field research and analyzing data
  • Strong people and communication skills: demonstrated to be a great team player. Ability to influence key stakeholders, work and communicate effectively with a diverse group with scientists and non-scientists to accomplish goals
  • Two to three years of experience in data analysis, consulting and problem solving in an agronomic or breeding environment
  • Strong computational background (e.g. programming in R, Python, Clojure, MATLAB and or SAS) and skills in data mining and predictive analytics methodologies
  • Experience in presenting, teaching and engaging with partners to align and execute on best practice to obtain superior results
5

Data Analytics / Statistical Scientist Resume Examples & Samples

  • Minimum of a Master’s Degree in Statistics, Biostatistics, Bioinformatics or a Statistics related discipline
  • Background and experience in spatial statistics and modeling of multi-layered geospatial data
  • Demonstrated computational skills and experience in R and SAS
  • Strong statistical skills in experimental design, general and generalized linear mixed models, and multivariate statistics
  • Experience presenting results to varied audiences & influencing project direction/strategy
  • Ability to actively engage with internal partners & external collaborators to align strategies & success measures in analytics
  • Proven consulting skills in a research environment
  • PhD in Statistics, Biostatistics, Bioinformatics or a Statistics related discipline
  • One or more years of experience after graduate degree
  • Background and experience in predictive analytics/machine learning
  • Background and experience in image analytics
  • Background and experience in computational statistics, computational mathematics, Bayesian statistics, and non-linear mixed models
  • Programming skills in MATLAB
  • Programming skills in Python
  • Knowledge and experience in plant biology, plant breeding, agronomy, and/or soil science
  • Knowledge and experience with multi-environment agricultural field trials
6

Principal Statistical Scientist Resume Examples & Samples

  • Master’s degree in statistics, biostatistics, or equivalent field with appropriate statistical coursework and at least 5 years of clinic al trial experience as a statistician; OR
  • PH.D. in statistics, biostatistics, or equivalent field with appropriate statistical coursework and at least 3 years of clinical trial experience as a statistician; OR
  • Equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities as demonstrated by consistently superior project-related performance and scientific leadership
  • Positive attitude and the ability to work well with others in a multi-disciplinary setting
  • Demonstrated knowledge of the drug development process
  • And a combination of two or more of the following
  • Proven performance in leading complex projects
  • Good organizational skills with the ability to adapt and adjust to changing priorities
  • Ability to mentor statisticians with regard to scientific principles, statistical methodology, and/or knowledge of a specific therapeutic area
  • Ability to communicate complex statistical concepts in a multi-disciplinary setting
  • Demonstrated knowledge in one or more therapeutic areas
  • LI-MC1
7

Statistical Scientist Resume Examples & Samples

  • Perform, advise, and review protocol development, sample size calculation, protocol and CRF review
  • Provide expert statistical input into and review of statistical deliverables (i.e. analysis plans, table shells, programming and table specifications, data review, tables, listings, figures and statistical sections for integrated reports) and data management deliverables (i.e. database design, validation checks and critical data)
  • Manage project budget and resource requirements. Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage scope, and provide revenue and resource forecasts for groups of studies
  • Lead the review of RFPs and QIPs; prepare proposal text and attend bid defense meetings for single studies
  • Manage customer relationships and provide training and guidance to lower level and new staff
8

Senior Biostatistician Statistical Scientist Resume Examples & Samples

  • PhD or educational equivalent in biostatistics or related field and 3 years relevant experience; Master's degree or educational equivalent in biostatistics or related field and 5 years relevant experience
  • Strong working knowledge of SAS computing package
  • Pharmaceutical, drug development, biotech or CRO industry experience
  • Excellent written and oral communication skills including grammatical/technical writing skills
  • Strong individual initiative, organization skills and multi-tasking ability
  • Ability to lead and co-ordinate small teams
9

Senior Biostatistician Statistical Scientist Resume Examples & Samples

  • Perform protocol development, sample size calculation, protocol and CRF review
  • Write statistical sections of integrated reports
  • Perform the review of RFPs and QIPs, prepare proposal text and attend bid defense meetings
  • Familiarity with moderately complex statistical methods that apply to applicable clinical trials
  • Ability to solve moderately complex problems
10

Senior Statistical Scientist Resume Examples & Samples

  • Develop as a primary contact as an expert in at least one therapeutic area including knowledge of therapeutic guidelines
  • Write publications
  • Advise on regulatory issues including integrated summaries of efficacy and safety, and liase with regulatory authorities on behalf of customer as required
  • Fulfill the Advisor/Lead role for a group of studies or integrated summaries. May fulfill the role of regulatory submission lead
  • Lead the review of RFPs and QIPs, prepare proposal text and participate in bid defense meetings for groups of studies
  • Develop customer relationships
  • Provide training, guidance and mentorship to lower level and new staff
  • Advanced knowledge of complex statistical methods that apply to Phase I-IV clinical trials
  • Familiarity with other statistical computing packages such as nQuery
  • Ability to effectively manage and lead multiple tasks and projects
  • Ability to lead teams within department and influence interdepartmental team activities
  • Proficient at solving complex scientific problems
  • Initiative in expanding into new technical areas or expanding in-house technological capabilities in a given area
  • PhD in biostatistics or related field and 5 years relevant experience; Master's degree in biostatistics or related field and 7 years relevant experience; or equivalent combination of education, training and experience
  • PHYSICAL REQUIREMENTS
  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech
  • Extensive use of keyboard requiring repetitive motion of fingers
  • Regular sitting for extended periods of time
  • Occasional travel
11

Associate Statistical Scientist Resume Examples & Samples

  • Clinical Development
  • Study Planning: With assistance of senior statistical scientists, reviews study protocols, authors statistical sections of protocols, develops independent data monitoring and endpoint committee charters
  • Develops the statistical and data analysis plans, and prepares the study randomization
  • Study Conduct: Reviews case report forms to ensure protocol objectives are met and project standards are maintained. Develops statistical programs as necessary to perform analyses, Review and approve analyses produced by statistical programming, ensuring the accuracy and validity of results
  • Analysis & Reporting: Author the clinical study report, and with assistance of senior scientists and cross-functional team members provides input into global health authority documents and regulatory response for health authority submissions
  • Contributes to study publications and presentations, and provides analytical support for exploratory activities such as personalized healthcare biomarker development and PK/PD modelling
  • Nonclinical Statistics
  • Study Planning: With assistance from senior staff, provides experimental design and analysis strategies to nonclinical projects in Research, Preclinical Development Science, Bioprocess Development and Manufacturing
  • Analysis and Reporting: With assistance from senior staff, performs statistical analyses for nonclinical studies, provides input to IND and BLA submissions and to regulatory response to global health authority investigations related to marketed products, and contributes to publications and presentations
  • Statistical Consulting: With assistance from senior staff, provides statistical advice to nonclinical investigators and contributes to the development of statistics courses
  • Functional Area
  • Understand and apply business requirements and processes. Participates in functional training
12

Senior Statistical Scientist Resume Examples & Samples

  • Minimum of 3 years of industrial engineering experience with performing of statistical analysis
  • MS degree in Statistics, Biostatistics, Data Science, Data Analytics, Machine Learning, Industrial Engineering from an accredited institution
  • Preferred: Experienced PhD (3+ years). Statistics, Biostatistics, Data Science, Data Analytics, Machine Learning, Industrial Engineering, or related field with strong grounding in statistical methods, programming, and analysis skills
13

Lead Statistical Scientist Resume Examples & Samples

  • Accomplish AML Program objectives through the effective oversight and support of critical AML applications
  • Properly identify, report and escalate issues which may impact the AML Office resulting from performance, functionality or changes within critical applications
  • Perform first level review and analysis of issues or escalations received from other areas within the AML Office
  • Assess the quality of the data for model development as well as inputs to the model, providing recommendations to improve the data quality at the source
  • Provide recommendations to improve monitoring systems and capabilities based on identified risk and control gaps
  • Assist in preparing materials required for Audits and Exams
  • Assist in the evaluation of projects and initiatives across BMO to properly identify areas of impact concerning critical AML applications
  • Scope of Scenarios & Parameters Change: Amend existing AML scenario logic and profiles
  • Scope of Scenarios & Parameters Design: End-to-end design and documentation
  • Integration Complexity: Single/few impacted systems or applications
  • Time span of longest component part: 9 to 12 months
  • Master degree in a quantitative discipline in Statistics, Mathematics, Engineering, Economics, Finance or MBA or other quantitative field
  • In-depth technical development skill and sound knowledge of advanced technology concepts
  • SAS Enterprise Guide/Enterprise Miner - SQL Queries required
  • Deep understanding of specialized technical/business processes within the bank
  • Good knowledge of Bank products, services, organization and interrelationships
  • In-depth knowledge of Financial Crimes, including current ML/TF behaviors would be an asset, not absolutely required
  • In-depth knowledge of Statistical Analysis and Human Behavior Modeling
  • Knowledge of Data Mining Tools
  • In-depth knowledge of parametric and non-parametric statistical techniques
14

Statistical Scientist Resume Examples & Samples

  • To ensure the smooth transfer of new products from other Abbott sites into ADD Longford
  • To assist in Product & Test Method development/improvement projects
  • To complete and document Technical Operations’ investigations per site procedures
  • As required perform the role of Principle Investigator for the acquisition of Human Specimens from internal sources
  • To relate information in the form of presentation to other team members and management
  • To ensure GMP and GLP requirements are maintained
  • Conduct business in a manner that will protect human health, safety and the environment by complying with all applicable EHS laws, as well as the Abbott Global & Technical Standards
15

Statistical Scientist Resume Examples & Samples

  • Successfully represent biostatistics/other biometrics functions on development teams
  • Provide statistical and strategic leadership for clinical development projects,
  • Directly responsible for the statistical integrity, adequacy, and accuracy of the clinical studies within the project, including activities to support personalized healthcare strategy
  • Company Biostatistics lead for Health Authority interactions
  • Keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review, conference attendance, etc
  • Leads Biostatistics and cross-functional initiatives
  • Leads the development of functional processes
  • Contributes to the biostatistics/scientific community by mentoring junior colleagues, actively serving as subject matter expert and participating in internal/external initiatives
16

Senior Statistical Scientist Resume Examples & Samples

  • Provide technical leadership across the organization
  • Develop sound and innovative experiment designs for laboratory, greenhouse and field trial experiments
  • Conduct statistical analysis for complex experiment designs and modeling projects
  • Develop predictive models using agronomic, geospatial or other high-dimensional data
  • Present statistical findings in a clear and actionable format
  • Lead initiatives to identify and implement process improvements
  • Identify opportunities to advance efficient processes related to data collection and analysis
  • Leverage analytical solutions from other organizations to solve chemistry research problems
  • Increase statistical awareness via training, computer applications, and technical papers
  • Collaborate with multi-disciplinary teams to optimize discovery and development strategies
  • Build collaborative networks within Monsanto and outside of Monsanto
  • Monitor advances in technical fields and implement advances as appropriate
  • Mentor junior statisticians and research staff
  • Influence leadership through impactful presentations
  • Minimum of a Master’s degree in Statistics or related field with ten or more years of related experience –OR- PhD in Statistics or related field with five or more years of experience. Related work experience would be in agronomy, biology, chemistry and/or breeding
  • Demonstrated technical expertise in experiment design across varied research settings
  • Experience in the following statistical techniques: linear and non-linear mixed modeling, experiment design, and statistical data mining
  • In-depth knowledge and extensive programming abilities in SAS and/or R
  • Desire and aptitude to develop R and Shiny programming skills
  • Effective communication and consulting skills across a culturally and academically diverse workforce
  • Strong desire and demonstrated success to train and develop others
  • Experience in generalized linear mixed modeling, multivariate and non-parametric analysis, and process improvement methodologies
  • Experience with data bases, computer systems for data/report storage and retrieval
  • In-depth knowledge and extensive programming abilities in R
  • Knowledge of other language for programming and statistical applications (for example: Matlab or Python)
  • Experience with Bayesian statistics applications
  • Experience working in the agriculture industry
17

Statistical Scientist Resume Examples & Samples

  • Partners with senior biostatistics staff and cross-functional members to provide technical and strategic input into clinical development plans
  • As part of clinical teams, collaborates in the design, planning, conduct, reporting and regulatory submissions of clinical studies to meet project objectives, including exploratory project activities such as biomarkers and PK/PD analysis
  • Collaborates with scientists and contributes to presentations/publications
  • Understands and apply business requirements and processes
  • Keeps abreast of new developments in statistics, drug development, and regulatory guidance through literature review, workshop attendance, etc
  • Contributes to the biostatistics/scientific community by partnering with senior staff, mentoring junior colleagues, and participating in internal/external initiatives
18

Biostatistician / Statistical Scientist Home Resume Examples & Samples

  • Contribute to protocol development through sample size calculation and statistical sections
  • Contribute to business development in collaboration with other colleagues with Quintiles
  • For senior roles, in addition to the above responsibilities
  • A limited amount of travel may be required
  • MINIMUM REQUIRED EDUCATION AND EXPERIENCE
19

Biostatisticians / Statistical Scientist Home Resume Examples & Samples

  • Provide statistical input into and review of statistical deliverables (i.e. analysis plans, table shells, programming and table specifications, data review, tables, listings, figures and statistical sections for integrated reports) and data management deliverables (i.e. database design, validation checks and critical data)
  • Provide training and guidance to lower level and new staff
  • Fulfill the Lead role for a group of studies or integrated summaries
  • Familiarity with moderately complex and some complex statistical methods that apply to late phase studies
  • Good working knowledge of SAS computing package: is an asset
  • Ability to effectively manage multiple tasks and projects
20

Senior Statistical Scientist Resume Examples & Samples

  • 5-10 years of experience in Clinical Development in a Pharmaceutical or Biotechnology setting
  • Experience providing statistical leadership at compound/indication level
  • Demonstrated statistical expertise and leadership in facilitating and optimizing the (pre/early/full-) clinical development strategy
  • Solid experience in applications of advanced statistical methodologies
  • Leading roles in regulatory submissions
  • Experience in interactions with major regulatory authorities preferred
  • Experience managing CRO preferred
  • Track record of innovation desired
  • Broad knowledge of clinical development and processes
21

Associate Director Statistical Scientist Resume Examples & Samples

  • Disease Area / TA/Indication level
  • Strong understanding of Franchise/Therapeutic Area and or regulatory activities. Expert scientific leadership skills demonstrated in facilitating and optimizing the (pre/early/full-) clinical development strategy. Strong track record for global scientific leadership in the development and evaluation of modern program/trial design methodologies
  • May have proven people leadership ability. Demonstrated strong skills in building partnerships and collaborations. Demonstrated skills in coaching and mentoring associates
22

Associate Statistical Scientist Resume Examples & Samples

  • Represent biostatistics and other biometrics functions on development teams
  • Provide statistical and strategic leadership for clinical development projects and exploratory biomarker analysis activities
  • Collaborates and consults with biomarker scientists in support of clinical development projects and presentations/publications and perform potentially complex biomarker analyses in support of these efforts
  • Keeps abreast of new developments in statistics, drug development, biomarker development, and regulatory guidance through literature review, conference attendance, and other scientific forums
  • Contributes to the biostatistics/scientific community by actively serving as subject matter expert and participating in internal/external initiatives