Director, Biostatistics
Sarepta Therapeutics · US
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Role summary
Sarepta Therapeutics seeks a Director of Biostatistics to lead statistical activities for genetic medicine programs targeting rare diseases including Duchenne muscular dystrophy. The role involves collaborating across teams to design studies, develop statistical analyses, author regulatory documentation, and provide data insights supporting drug development from preclinical through regulatory submission stages.
What they're looking for
- Ph.D. in statistics or related discipline with 9+ years industry experience, or Master's with 10+ years
- Demonstrated clinical trial design, analysis, and reporting expertise
- In-depth knowledge of frequentist and Bayesian statistical methods
- Proficiency in SAS and R programming languages
- Knowledge of FDA, EMA, and ICH regulations and guidelines
- Experience with NDA, MAA, or regulatory submissions preferred
- Proficiency in statistical design software such as EAST
What you'll be doing
- Lead statistical planning and execution across DMD or siRNA platform compounds or studies
- Develop statistical models for robust clinical trial designs and address statistical issues
- Author statistics sections in clinical protocols and review statistical analysis plans
- Design randomization schedules and perform quality control of statistical deliverables
- Conduct exploratory analyses beyond pre-specified plans to inform program decisions
Privacy & handoff
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