Associate Director, Biostatistics - Genetic Medicine
Regeneron
August 13, 2026
On-site
Tarrytown, NY
Clinical Research and Development
In This Role, a Typical Day Might Include
- Lead Biostatistics efforts with cross-functional teams to articulate drug development questions, assess endpoint feasibility, frame statistical approaches, and design/analyze clinical experiments and interventional studies.
- Represent statistical issues in regulatory agency meetings.
- Lead development and delivery of training to non-statistical colleagues; develop 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, and Medical Writing to design and analyze clinical trials.
- Lead regulatory interaction materials (e.g., draft analysis plan, review TFLs, develop advisory committee slides).
- Lead/contribute to process improvement, technical working groups, and SOP development; set deliverable timelines/expectations.
- Evaluate software appropriateness for planned analyses; determine needs for novel statistical methodology/tools.
- Prepare presentations and written reports; co-present to management.
- Conduct research in innovative statistical methods and provide training to non-statisticians.
To be considered, you must have
- PhD (or equivalent) in statistics/biostatistics with >6 years in pharma OR MS in statistics/biostatistics with >11 years in pharma.
Preferred
- Hematology, IO, non-oncology, Multiple Myeloma experience (or similar therapeutic area).
Additional qualifications/skills
- Time to Event (TTE) experience.
- Knowledge of drug discovery/development; integrate statistical concepts into strategies.
- Strong influence/leadership and cross-functional collaboration.
- Ability to work in fast-paced environments; critical thinking, time management, effective communication.
- Solid knowledge of statistical analysis methodologies and experimental/clinical trial design.
- Expertise in statistical software.
- Lead Biostatistics efforts with cross-functional teams to articulate drug development questions, assess endpoint feasibility, frame statistical approaches, and design/analyze clinical experiments and interventional studies.
- Represent statistical issues in regulatory agency meetings.
- Lead development and delivery of training to non-statistical colleagues; develop 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, and Medical Writing to design and analyze clinical trials.
- Lead regulatory interaction materials (e.g., draft analysis plan, review TFLs, develop advisory committee slides).
- Lead/contribute to process improvement, technical working groups, and SOP development; set deliverable timelines/expectations.
- Evaluate software appropriateness for planned analyses; determine needs for novel statistical methodology/tools.
- Prepare presentations and written reports; co-present to management.
- Conduct research in innovative statistical methods and provide training to non-statisticians.
To be considered, you must have
- PhD (or equivalent) in statistics/biostatistics with >6 years in pharma OR MS in statistics/biostatistics with >11 years in pharma.
Preferred
- Hematology, IO, non-oncology, Multiple Myeloma experience (or similar therapeutic area).
Additional qualifications/skills
- Time to Event (TTE) experience.
- Knowledge of drug discovery/development; integrate statistical concepts into strategies.
- Strong influence/leadership and cross-functional collaboration.
- Ability to work in fast-paced environments; critical thinking, time management, effective communication.
- Solid knowledge of statistical analysis methodologies and experimental/clinical trial design.
- Expertise in statistical software.