Manager, Biostatistics

Regeneron Pharmaceuticals•Warren, MI

9d•Hybrid

About The Position

This position is for a qualified statistician/biostatistician to support the Statistical Innovation and Multimodal Evidence Synthesis (SIMES) team within Global Development at Regeneron. The incumbent will work with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints and frame statistical approaches to address those questions, design clinical experiments and interventional studies to generate and analyze the resulting data, and work with teams to appropriately interpret the results and make decisions. The incumbent will work with clinical trial data, real world data (RWD) integrations with clinical trials, as well as other external data sources. They will use innovative trial designs including but not limited to Bayesian, propensity scores and other methods, for causal inference. The incumbent will co-author any research protocols, statistical analysis plans, and perform statistical analyses for model informed drug development. The incumbent will leverage AI/ML methods for predictive modeling, code generation, data extraction workflows, and to enhance model development and deployment. The incumbent will also develop and deliver training to non-statistical colleagues, collaborate on development of new infrastructure and processes, and influence the external pharmaceutical industry and regulatory environment through participation in professional associations, conferences, and publications.

Requirements

PhD or equivalent degree in statistics/biostatistics with > 2 years’ experience or related disciplines with internship experience, OR MS degree in statistics/biostatistics with >7 years’ experience in the pharmaceutical industry as a statistician.
Excellent influence and leadership skills, and a demonstrated ability to collaborate in a cross-functional environment.
Must be able to work productively in a fast-paced collaborative environment, with demonstrated critical thinking skills, time management skills, and effective communication skills.
Solid knowledge of statistical analysis methodologies, experimental and clinical trial design.
Expertise in statistical software such as R or SAS is required.

Nice To Haves

Experience with or strong willingness to learn LLM agents (e.g., Claude, Gemini) for statistical workflows preferred.

Responsibilities

Interacts with Medical and Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statisticians and AI scientists, Statistical Programming, Data Management, Medical Writing, and others to design methodologies to advance clinical development.
Develops any research proposals or protocols if needed and statistical analysis plans and determines appropriate statistical methodology for data analysis.
Evaluates appropriateness of available software for planned analyses and determines needs for use of novel statistical methodology or tools.
Analyzes data and interprets results from clinical trials and of data from non-trial sources (RWD) to facilitate program-level decision making.
Prepares presentations and written reports to effectively communicate results to the project team, management, and regulatory agencies.
Co-presents findings to management.
Is involved in research activities for innovative statistical methods and applications in clinical trial development (e.g., external control arms, hybrid designs, master protocols), with expectation of publications and methodological contributions, as well as providing training to non-statisticians.