Regeneron · 2 weeks ago
Associate Director, Biostatistics - Hematology
Regeneron is seeking a qualified statistician/biostatistician to support Clinical Biostatistics with Global Development. The Associate Director will lead the Biostatistics department, articulate drug development questions, design clinical experiments, and mentor less experienced statisticians while representing the company in regulatory meetings and professional associations.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
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 contributions to the preparation of material to be used in regulatory interactions, including drafting analysis plan and reviewing TFLs to be used in regulatory meetings, slides for advisory committee meetings, etc
Lead and contributes to process improvement and technical working groups and sets timelines and expectations for the deliverables
Authors new/revised SOPs and contributes to cross-functional EPIC workstreams
Evaluate appropriateness of available software for planned analyses and determines needs for use of novel statistical methodology or tools
Prepare 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 as well as providing training to non-statisticians
Qualification
Required
PhD or equivalent degree in statistics/biostatistics with >6 years of experience in the pharmaceutical industry OR MS degree in statistics/biostatistics with >11 years of experience
Time to Event (TTE) experience
Knowledge of drug discovery and development and ability to integrate statistical concepts into drug discovery and development strategies
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
Preferred
Hematology, IO, non-oncology, Multiple Myeloma experience or similar Therapeutic Area
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
2026-01-13
2026-01-09
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