Director, Biostatistics
Sarepta Therapeutics
August 21, 2026
Remote friendly (United States)
United States
Clinical Research and Development
The person in this position will serve as a project biostatistician responsible for statistical activities at the compound level or study level in DMD or siRNA platforms. Beyond traditional SAP-driven deliverables, the role requires hands-on data exploration, partnership with clinical development to shape scientific questions, and delivery of rapid insights using modern analytical tools.
Responsibilities:
- Coordinate planning and execution of statistical deliverables (internal and external/CRO)
- Lead/conduct statistical modeling; identify/address statistical issues
- Contribute to clinical protocol development (author Statistics section; review other sections)
- Author/review statistical analysis plans; develop shells for tables/figures/listings
- Review CRF designs; design/specify randomization schedules and approve test randomization lists
- Provide input to DMC charters and other study-level documents; review analysis dataset specifications
- Perform QC/QA of statistical deliverables (validate key results)
- Conduct ad hoc/exploratory analyses beyond SAP
- Contribute to clinical study reports (methods/interpretation)
- Support regulatory submissions (IND/NDA/MAA); address FDA/regulatory and IRB/EC comments
- Support publications; drive standardization/process improvement; mentor junior team members
Qualifications:
- Ph.D. (strongly preferred) with 9+ years, or Master’s with 10+ years in statistics/related discipline (pharma/biotech)
- Demonstrated experience designing, analyzing, and reporting clinical trials
- Preferred: NDA/MAA or other regulatory submissions
- In-depth clinical trial statistical methods (frequentist and Bayesian); FDA/EMA/ICH knowledge
Skills/Tools (required unless noted):
- SAS and R; Python/other languages a plus; EAST proficiency
- Knowledge of SDTM/ADaM; ability to oversee CRO/statistical services
- Ability to work independently and lead multiple studies; strong written/oral communication
Preferred/Desirable:
- Gene therapy/rare disease/neuromuscular disease knowledge; external control arms/RWE/observational methods
Benefits: Hybrid work; salary range $206,000–$257,500/year.
Application instructions: Candidates must be authorized to work in the U.S.
Responsibilities:
- Coordinate planning and execution of statistical deliverables (internal and external/CRO)
- Lead/conduct statistical modeling; identify/address statistical issues
- Contribute to clinical protocol development (author Statistics section; review other sections)
- Author/review statistical analysis plans; develop shells for tables/figures/listings
- Review CRF designs; design/specify randomization schedules and approve test randomization lists
- Provide input to DMC charters and other study-level documents; review analysis dataset specifications
- Perform QC/QA of statistical deliverables (validate key results)
- Conduct ad hoc/exploratory analyses beyond SAP
- Contribute to clinical study reports (methods/interpretation)
- Support regulatory submissions (IND/NDA/MAA); address FDA/regulatory and IRB/EC comments
- Support publications; drive standardization/process improvement; mentor junior team members
Qualifications:
- Ph.D. (strongly preferred) with 9+ years, or Master’s with 10+ years in statistics/related discipline (pharma/biotech)
- Demonstrated experience designing, analyzing, and reporting clinical trials
- Preferred: NDA/MAA or other regulatory submissions
- In-depth clinical trial statistical methods (frequentist and Bayesian); FDA/EMA/ICH knowledge
Skills/Tools (required unless noted):
- SAS and R; Python/other languages a plus; EAST proficiency
- Knowledge of SDTM/ADaM; ability to oversee CRO/statistical services
- Ability to work independently and lead multiple studies; strong written/oral communication
Preferred/Desirable:
- Gene therapy/rare disease/neuromuscular disease knowledge; external control arms/RWE/observational methods
Benefits: Hybrid work; salary range $206,000–$257,500/year.
Application instructions: Candidates must be authorized to work in the U.S.