Associate Director, Biostatistics - Genetic Medicine
Regeneron
July 01, 2026
Remote friendly (Tarrytown, NY)
United States
Clinical Research and Development
In This Role, a Typical Day Might Include
- Lead efforts of the Biostatistics department with cross-functional teams to articulate drug development questions, assess endpoint feasibility, frame statistical approaches, design clinical experiments/interventional studies, analyze resulting data, and interpret results to support decisions.
- Represent statistical issues in regulatory agency meetings.
- Lead development and delivery of training to non-statistical colleagues.
- Lead development of new infrastructure and processes.
- Represent the company in professional associations, conferences, and publications.
- As an Associate Director: mentor and oversee less experienced statisticians; potential to manage full-time staff.
This Role Might Be For You If Can
- Represent Biostatistics at Global Clinical sub-teams.
- Interact with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statistical Programming, Data Management, Medical Writing, and others to design and analyze clinical trials.
- Lead regulatory interaction contributions (e.g., draft analysis plan, review TFLs, develop advisory committee slides).
- Lead and contribute to process improvement/technical working groups; set timelines/expectations; author/update SOPs; contribute to cross-functional EPIC workstreams.
- Evaluate software appropriateness for planned analyses; determine need for novel statistical methodology/tools.
- Prepare presentations/written reports for project teams, management, and regulatory agencies; co-present to management.
- Participate in research on innovative statistical methods; provide training to non-statisticians.
To Be Considered, you must have
- PhD (or equivalent) in statistics/biostatistics with >6 years’ pharmaceutical industry experience OR MS with >11 years’ experience.
- Preferred: Hematology, IO, non-oncology, Multiple Myeloma (or similar therapeutic area) experience.
- Time to Event (TTE) experience.
- Knowledge of drug discovery/development; ability to integrate statistical concepts into development strategies.
- Excellent influence/leadership; ability to collaborate cross-functionally.
- Ability to work in a fast-paced collaborative environment; critical thinking, time management, effective communication.
- Solid knowledge of statistical analysis methodologies and experimental/clinical trial design.
- Expertise in statistical software.
- Lead efforts of the Biostatistics department with cross-functional teams to articulate drug development questions, assess endpoint feasibility, frame statistical approaches, design clinical experiments/interventional studies, analyze resulting data, and interpret results to support decisions.
- Represent statistical issues in regulatory agency meetings.
- Lead development and delivery of training to non-statistical colleagues.
- Lead development of new infrastructure and processes.
- Represent the company in professional associations, conferences, and publications.
- As an Associate Director: mentor and oversee less experienced statisticians; potential to manage full-time staff.
This Role Might Be For You If Can
- Represent Biostatistics at Global Clinical sub-teams.
- Interact with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statistical Programming, Data Management, Medical Writing, and others to design and analyze clinical trials.
- Lead regulatory interaction contributions (e.g., draft analysis plan, review TFLs, develop advisory committee slides).
- Lead and contribute to process improvement/technical working groups; set timelines/expectations; author/update SOPs; contribute to cross-functional EPIC workstreams.
- Evaluate software appropriateness for planned analyses; determine need for novel statistical methodology/tools.
- Prepare presentations/written reports for project teams, management, and regulatory agencies; co-present to management.
- Participate in research on innovative statistical methods; provide training to non-statisticians.
To Be Considered, you must have
- PhD (or equivalent) in statistics/biostatistics with >6 years’ pharmaceutical industry experience OR MS with >11 years’ experience.
- Preferred: Hematology, IO, non-oncology, Multiple Myeloma (or similar therapeutic area) experience.
- Time to Event (TTE) experience.
- Knowledge of drug discovery/development; ability to integrate statistical concepts into development strategies.
- Excellent influence/leadership; ability to collaborate cross-functionally.
- Ability to work in a fast-paced collaborative environment; critical thinking, time management, effective communication.
- Solid knowledge of statistical analysis methodologies and experimental/clinical trial design.
- Expertise in statistical software.