Principal Scientist, Biostatistics, Clinical Safety Statistics

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 develop strategic and statistical plans and conduct analyses of safety data from clinical trials and post-marketing sources for drug and vaccine development programs. Their work informs product safety profiles and benefit-risk assessments throughout the product life cycle.

• Provide statistical leadership for compound safety evaluation strategies and analyses in the Oncology Therapeutic Area; support CSS projects in other therapeutic areas as needed.
• Partner with Clinical Safety Risk Management, Early and Late Development Statistics, Epidemiology, Programming, and other RMST functions to plan and conduct aggregate safety evaluations for oncology projects.
• Ensure that safety deliverables meet analysis requirements, applicable SOPs, and regulatory guidance.
• Communicate safety analysis results and recommendations to cross-functional teams, management, regulators, and investigators.
• Develop processes, job aids, statistical methods, and tools for safety evaluation that address scientific and business needs.

• PhD or equivalent degree in statistics, biostatistics, or a related discipline with at least 6 years of relevant work experience, or a master's degree with at least 9 years of relevant work experience.

• Strong knowledge of statistical methods, including survival analysis, meta-analysis, Bayesian methods, and approaches to control confounding, such as matching and propensity score analysis. Proficiency in statistical software, such as SAS or R.
• Strong knowledge of regulatory requirements for analyzing and reporting safety data.
• Knowledge of and experience in clinical trial design and analysis, including the analysis and interpretation of integrated safety data.
• Knowledge of statistical methods for analyzing randomized and non randomized clinical trial and real-world data.
• Strong communication, project management, and leadership skills, including the ability to influence cross-functional teams and align priorities across the therapeutic area.

• Knowledge of the drug and vaccine development process, from discovery and preclinical research through Phase 1-3 clinical trials, NDA review, and post-marketing evaluation.
• Interest in developing or applying novel statistical methods for safety data monitoring, evaluation, and benefit-risk assessment, with publications in peer-reviewed statistical or medical journals.
• Knowledge of and experience in developing or applying AI tools in drug development projects.
• Understanding of disease biology.

• Biostatistics, Clinical Trials, Data Management, Data Science, Numerical Analysis, Scientific Modeling, Statistical Analysis

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We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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