Senior Director, Biostatistics - Immunology & Inflammation
Regeneron
August 23, 2026
Remote friendly (Warren, NJ)
United States
Clinical Research and Development
Discover Your Role
- Determine Department goals and resource allocation with the Department Executive Director.
- Ensure project teams have high-quality statistical support for clinical development plans, study design, and operational aspects.
- Provide statistical representation in key project decisions and regulatory meetings; serve as departmental representative on corporate-wise teams.
- Oversee statistical reporting; review critical documents (SAP, analysis results presentations, CSR, integrated summaries) and ensure compliance with data submission guidelines.
- Plan and track project activities, timelines, and resource use; justify resource needs; optimize resource utilization; conduct long-range planning.
- Provide technical direction and mentoring; recruit, develop, and retain high-quality staff.
- Maintain awareness of industry standards and regulatory requirements; harmonize policies/SOPs with standards and develop policies aligned with corporate values.
This Role Requires
- Ph.D. in statistics (10+ years) or MS in statistics (15+ years) in biotech/pharma/health industry; significant interaction with FDA and EMEA; 6+ years successful project and people management; expertise across multiple therapeutic areas.
- Active research interests related to clinical trials.
- Ability to exercise judgment in applying/modifying procedures and methods to specific problems.
- Independent, self-directed, high-energy; creativity and attention to detail.
- Strong leadership, project management, teamwork, and interpersonal skills; excellent presentation skills.
- Experience leading major process/technology initiatives across functional groups.
- Broad understanding of advanced statistical concepts/techniques.
- Ability to represent Biostatistics and Data Management with senior leadership/cross-functional committees.
- Thorough knowledge of pharmaceutical clinical development and lifecycle management; regulatory guidelines and statistical practice.
- Understanding of drug discovery/development process globally.
- Strong administrative skills and ability to influence others.
When & Where
- Work location: Tarrytown, NY; Cambridge, MA; or Warren, NJ. 4 days/week on site; up to 25% travel may be required.
- Determine Department goals and resource allocation with the Department Executive Director.
- Ensure project teams have high-quality statistical support for clinical development plans, study design, and operational aspects.
- Provide statistical representation in key project decisions and regulatory meetings; serve as departmental representative on corporate-wise teams.
- Oversee statistical reporting; review critical documents (SAP, analysis results presentations, CSR, integrated summaries) and ensure compliance with data submission guidelines.
- Plan and track project activities, timelines, and resource use; justify resource needs; optimize resource utilization; conduct long-range planning.
- Provide technical direction and mentoring; recruit, develop, and retain high-quality staff.
- Maintain awareness of industry standards and regulatory requirements; harmonize policies/SOPs with standards and develop policies aligned with corporate values.
This Role Requires
- Ph.D. in statistics (10+ years) or MS in statistics (15+ years) in biotech/pharma/health industry; significant interaction with FDA and EMEA; 6+ years successful project and people management; expertise across multiple therapeutic areas.
- Active research interests related to clinical trials.
- Ability to exercise judgment in applying/modifying procedures and methods to specific problems.
- Independent, self-directed, high-energy; creativity and attention to detail.
- Strong leadership, project management, teamwork, and interpersonal skills; excellent presentation skills.
- Experience leading major process/technology initiatives across functional groups.
- Broad understanding of advanced statistical concepts/techniques.
- Ability to represent Biostatistics and Data Management with senior leadership/cross-functional committees.
- Thorough knowledge of pharmaceutical clinical development and lifecycle management; regulatory guidelines and statistical practice.
- Understanding of drug discovery/development process globally.
- Strong administrative skills and ability to influence others.
When & Where
- Work location: Tarrytown, NY; Cambridge, MA; or Warren, NJ. 4 days/week on site; up to 25% travel may be required.