Associate Principal Scientist, Biostatistics, Clinical Safety Statistics

** Job Description
** In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company’s renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.
** Position

Description:

** Associate Principal Scientist, Clinical Safety Statistics (CSS), Biostatistics and Research Decision Sciences (BARDS), Statisticians in the Clinical Safety Statistics (CSS) group analyze safety data from clinical trials for drug and vaccine development programs to help inform the safety profile of products throughout their life cycle.
** Responsibilities:
*** Provide statistical support and leadership for projects related to the evaluation of clinical safety data.
* Interact with cross-functional Risk Management Safety Teams (RMSTs) on planning and executing evaluations of safety data for clinical development programs.
* Design, develop and evaluate processes, methods and tools for safety data evaluation.
** Primary activities:
*** Collaborate with Clinical Safety and Risk Management, Clinical Research, Early Development Statistics, Late Development Statistics, Epidemiology, Scientific Programming, and other groups, on drug/vaccine safety evaluation from the Investigational New Drug (IND) through New Drug Application (NDA) to post-marketing phases of development programs.
* Provide statistical support and leadership to cross-functional RMSTs for strategic planning and statistical analysis activities supporting safety evaluations.
* Collaborate on planning and executing aggregate safety evaluations for: clinical trials during a development program, regulatory documents (e.g., DSUR, IB), and responses to safety-related inquiries.  Ensure that all deliverables meet analysis requirements, standard operating procedures, and regulatory requirements.
* Evaluate the appropriateness of available software for planned analyses and ascertain the need for development of novel statistical methods or programming.
* Design, develop and evaluate processes, methodology and tools for product safety evaluation to support ongoing aggregate safety data analysis.
* Prepare oral and written reports and presentations to effectively communicate safety analysis results to project teams, management, regulatory agencies, or individual investigators.
* Stay current regarding regulatory guidance and methods for the evaluation of safety data.
* Participate in research activities for innovative statistical methods and applications in clinical safety evaluation.
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* Education:

*** PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 3 years relevant work experience, or master’s with a minimum of 6 years relevant work experience.
*
* Required:

*** Solid knowledge of statistical analysis methodologies, including survival analysis, meta-analysis and Bayesian analysis methods.
* Knowledge of and experience with clinical trial design and analysis.
* Knowledge of and experience with the analysis and interpretation of (integrated) safety data.
* Knowledge of and experience with the specifications, creation, and use of SDTM and ADaM datasets.
* Solid knowledge of statistical and data processing software e.g. SAS and/or R and R-Shiny, including generation of statistical graphics.
* Ability to function effectively in a team environment with personnel from different functional areas.
* Strong oral and written communication, organizational, and project management skills.
** Preferred:
*** Knowledge of statistical methods for the analysis of observational (epidemiologic) data, including methods to control confounding (e.g., matching, propensity score analysis, etc.)
* Knowledge of regulatory requirements regarding safety signal evaluation, identification, and reporting.
* Knowledge of drug development process from Discovery, Preclinical Research, Clinical Trials (Phase 1, 2 and
3), NDA review, through post-market safety monitoring.
*…