Senior Scientist, Biostatistics, Clinical Safety Statistics

BARDS (Biostatistics and Research Decision Sciences) is 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 in pre- and post-marketing development stages.

Provide statistical support for program-level evaluation of clinical safety data. Interact with members of cross-functional safety teams (e.g., Safety Physicians and Scientists, Clinical Trial Physicians and Scientists, Epidemiologists, Regulatory Liaisons, Early and Late Development Statisticians, Statistical Programmers, and others) on the planning and execution of ongoing safety evaluations for products across pre-marketing and post-marketing development stages. Design, develop and evaluate processes and tools for product safety evaluation, including ongoing aggregate safety evaluation at the program level. Primary activities: Provide statistical support to cross-functional safety teams including strategic planning and scientific reasoning activities that facilitate safety evaluation. Plan and execute ongoing aggregate safety evaluations, including cumulative meta-analysis of safety. Design, develop and apply safety evaluation methods, processes, standards, and tools, including enhanced graphical analyses. Collaborate with other statisticians and statistical programming staff to ensure high-quality, safety-related deliverables, which meet analysis requirements, internal standard operating procedures, and external regulatory requirements. Prepare oral or written reports to effectively communicate results of safety evaluations to project teams. Ascertain the need for development of novel statistical methodology and evaluate the appropriateness of available software for implementing the planned analyses. Conduct research on innovative statistical methods and applications in clinical safety evaluation. Education and Minimum Requirement: PhD or equivalent degree in statistics/biostatistics or related discipline, or a master’s degree with a minimum of 3 years of relevant experience. Required Skills and Experience: Solid understanding of study design and statistical analysis methods, particularly survival analysis, meta-analysis, and Bayesian methodologies. Working knowledge of statistical and data processing software such as SAS and R (R-Shiny a plus). Strong oral and written communication skills, with the ability to collaborate effectively with colleagues from different functional backgrounds. Strong initiative, motivation, attention to detail, commitment to high-quality execution, and ability to manage multiple priorities. Preferred Skills and Experience: Familiarity with CDISC standards, including SDTM and ADaM datasets. Knowledge of statistical methods for analyzing observational epidemiologic data, including approaches to controlling confounding, such as matching and propensity score methods. Proficiency in using AI tools to support writing activities (including summaries, reports, presentations, and manuscripts) as well as programming and other analytical tasks. Knowledge of regulatory requirements related to safety signal detection, evaluation, and reporting. Understanding of the drug discovery and development process. Understanding of disease biology Interest in statistical research, particularly methodologies for safety monitoring, safety evaluation, and benefit-risk assessment; publication(s) in peer-reviewed statistical or medical journals a plus. BARDS2020 #EligibleforERP Required Skills: Biostatistics, Clinical Trials, Data