Director, Biostatistics

Sarepta Therapeutics Inc

Sarepta Therapeutics seeks a Director of Biostatistics to lead statistical strategy and execution for clinical trials across genetic medicine programs. The role combines hands-on technical work with strategic program leadership, requiring extensive pharmaceutical or biotech experience and expertise in adaptive trial design and regulatory submissions.

Responsibilities

Direct statistical strategy and execution for assigned clinical trials from protocol through database lock and reporting
Lead statistical study design including endpoints, sample size, randomization, and interim analyses
Progress to Program Statistical Lead role providing strategic oversight across development stages
Oversee regulatory submissions, pivotal analyses, and health authority interactions
Manage external CRO and vendor statistical deliverables while maintaining accountability for quality

Requirements

Ph.D. in Statistics/Biostatistics with 9+ years experience, or Master's with 10+ years
Sponsor-side pharmaceutical or biotechnology clinical trial experience strongly preferred
Proficiency in R and/or SAS for independent statistical analysis development
Demonstrated expertise in adaptive trial design and clinical trial methodology
Experience leading regulatory submissions and interactions with health authorities
Strong cross-functional collaboration and scientific communication skills

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Vacancy posted 8 days ago

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