Regeneron · 10 hours ago
Senior Director, Biostatistics - Immunology & Inflammation
Regeneron is seeking a Senior Director, Biostatistics to drive their Immunology and Inflammation therapeutic area. The role involves strategic and operational activities, leading teams, and ensuring high-quality statistical support for clinical development plans and study designs.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
Determining Department goals and resource allocation in conjunction with the Department Executive Director
Ensure project teams have high quality statistical support for creation of clinical development plans, study design, and operational aspects
Work with senior management to ensure statistical representation in key project decisions and regulatory meetings. Serve as departmental representative on corporate‐wise teams
Oversee process for statistical reporting. Review critical documents, such as SAP, analysis results presentations, CSR, and integrated summaries. Ensure compliance with data submission guidelines
Plan and track project activities, timelines, and resource use. Provide justification for planned resource needs. Seek to optimize resource utilization across projects or areas. Effect long‐range planning
Ensure technical direction and mentoring for staff. Encourage personal development in the context of project work. Learn and apply techniques to promote teamwork, quality, and motivation. Recruit, develop, and retain high quality staff
Maintain awareness of industry standards and regulatory requirements. Alert staff to new or changing standards. Within area of control, harmonize policies with departmental guidelines SOPs and with industry standards. Develop polices promoting application of corporate values in work practices
Qualification
Required
Ph.D. in statistics or related discipline with 10+ years of experience (or MS in statistics or related discipline with 15+ years) in the biotechnology, pharmaceutical or health related industry, including significant interaction with both FDA and EMEA, history of successful project and people management (6+ years), and expertise in multiple therapeutic areas
Active research interests in area related to clinical trial
Demonstrated ability to work in a changing and busy environment and to exercise judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards for application to specific problems or tasks
Ability to work independently – self‐directed, high energy and strong work ethic. High degree of creativity, latitude and attention to detail required
Demonstrated strong leadership, project management, teamwork and interpersonal skills
Excellent presentation skills
Experience and proven ability leading and managing major process and technology initiatives with utilization and impact across multiple functional groups
Broad knowledge and superior understanding of advanced statistical concepts and techniques
Outstanding ability and skills to effectively represent Biostatistics and Data Management in interactions with senior management or cross‐functional committees
Thorough knowledge of pharmaceutical clinical development and life cycle management; ability to innovatively apply technical principles, theories and concepts to clinical drug development leading to regulatory approvals
Thorough working knowledge of regulatory guidelines on drug development, regulatory submissions, and statistical practice
Understanding of the drug discovery and development process, regionally and globally
Strong administrative skills
Ability to influence others to achieve results
Benefits
Health and wellness programs (including medical, dental, vision, life, and disability insurance)
Fitness centers
401(k) company match
Family support benefits
Equity awards
Annual bonuses
Paid time off
Paid leaves (e.g., military and parental leave)
Company
Regeneron
Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.
H1B Sponsorship
Regeneron has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (157)
2024 (128)
2023 (128)
2022 (137)
2021 (104)
2020 (122)
Funding
Current Stage
Public CompanyTotal Funding
$15.93MKey Investors
U.S. Department of Health & Human Services
2024-07-11Post Ipo Equity· $2.03M
2023-10-18Post Ipo Equity· $5M
2016-08-22Post Ipo Equity· $8.9M
Leadership Team
Recent News
Pharmaceutical Technology
2026-01-16
2026-01-16
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