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.
The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment, transparent communication, and effective management of product risk profiles across our company Research Laboratories pre- and post-marketing development stages.
Key responsibilities for the position
- 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. Serve as a statistical representative and core member on the RMST.
- Design, develop and evaluate processes, methods and tools for safety data evaluation.
Primary activities for the position
- 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.
Education and Minimum Requirement:
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 Skills and Experience:
- 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.
- Must also demonstrate a desire to learn, be proactive and motivated, and exhibit consistent focus on details and execution.
Preferred Skills and Experience:
- 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.
- An interest in statistical research activities particularly those related to the development and application of novel methods for safety data monitoring, evaluation, and benefit-risk assessment.
- Publications in peer reviewed statistical/medical journals.
- An understanding of disease biology and drug discovery and development.
- Expertise with AI to facilitate writing (summaries, reports, manuscripts, etc.), programming, and other types of tasks.
BARDS2020
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