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.
Statisticians in the Clinical Safety Statistics (CSS) group strategize, plan and analyze safety data from clinical trials and post-marketing sources for drug and vaccine development programs to help inform the safety profile and benefit-risk understanding of products throughout their life cycle.
Key Responsibilities for this Position:
- Serve as the CSS therapeutic area lead for the vaccine and infectious disease (VID) projects.
- Provide statistical leadership and support to the Risk Management and Safety Teams (RMSTs) in the strategic planning and execution of compound level safety evaluation across product life cycle in vaccine and drug programs
- Design, develop and implement innovative statistical methods and tools for safety evaluation.
Primary Activities:
- Provide statistical leadership for compound safety evaluation strategy and analysis in vaccines and infectious diseases; support CSS projects in other therapeutic areas as needed.
- Partner with Clinical Safety Risk Management, Early/Late Development Statistics, Epidemiology, Programming, and other RMST functions to plan and execute on aggregate safety evaluation in vaccine and drug projects
- Ensure safety deliverables meet analysis requirements, relevant SOPs and regulatory guidance.
- Communicate safety-analysis results and recommendations to teams, management, regulators, and investigators.
- Develop processes, job aids, statistical methods, and tools for safety evaluation that address scientific and business needs
Education:
PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 6 years relevant work experience, or master’s with a minimum of 9 years relevant work experience.
Required:
- Solid knowledge of statistical analysis methodologies. Solid experience of using statistical software (eg SAS or R).
- Solid knowledge of regulatory requirements regarding the analysis and reporting of safety data.
- Strong project management and leadership skills, including the ability to influence cross-functional teams and align priorities at the Therapeutic Area level.
- Knowledge of and experience with clinical trial design and analysis. Experience with the analysis and interpretation of integrated safety data
- Knowledge of statistical methods appropriate for the analysis of clinical trial data in both randomized and non-randomized studies
Preferred:
- Solid Knowledge of drug/vaccine development process from discovery, preclinical research, clinical trials (Phase 1, 2 and 3), NDA review to post-marketing evaluation
- Knowledge and experience in developing/applying AI tools in drug and vaccine development projects.
Required Skills:
Biostatistics, Clinical Risk Management, Clinical Study Design, Clinical Trials, Clinical Trials Analysis, Data Management, Data Science, Numerical Analysis, Safety Management, Statistical Analysis, Statistical Software, Strategic Management, Strategic Planning
Preferred Skills:
