Director, Biostatistics
Sarepta Therapeutics
13 days ago
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
The person in this position will serve as project biostatistician responsible for statistical activities at the compound or study level in DMD or siRNA platforms.
Responsibilities:
- Coordinate planning and execution of statistical deliverables with internal/external teams (e.g., CROs).
- Lead statistical modeling to support robust study designs and address statistical issues.
- Contribute to clinical protocol development (author/review Statistics section).
- Author/review statistical analysis plans (SAPs), ISS/ISE analyses, and shells for tables/figures/listings.
- Review CRF designs; design/specify randomization schedules and review test randomization lists.
- Provide statistical input to DMC/independent review charters and other study documents; review analysis dataset specifications.
- Perform QC/QA of statistical deliverables and validate key results.
- Conduct ad hoc/exploratory analyses beyond SAP; partner early with Clinical/Medical/Regulatory on scientific questions.
- Use modern tools (R, Python, interactive visualization apps) with SAS; maintain documentation/traceability.
- Support IND/NDA/MAA regulatory submissions; respond to FDA/regulatory comments and review IRB/EC comments.
- Contribute to clinical study reports, publications, and standardization/process improvements; mentor junior biostatisticians.
Qualifications:
- Ph.D. (strongly preferred) with 9+ years, or Master’s with 10+ years in statistics/related field (pharma/biotech).
- Demonstrated experience designing, analyzing, and reporting clinical trials.
- Knowledge of statistical methods (frequentist and Bayesian) and FDA/EMA/ICH guidelines.
- Proficient in SAS and R (Python/other languages a plus); EAST preferred.
- Working knowledge of SDTM/ADaM; ability to oversee CRO/contractor statistical services.
Desirable:
- Rare disease/gene therapy/neuromuscular experience; NDAs/MAAs; external control arms/RWE/observational methods.
Benefits (explicit): Physical and Emotional Wellness; Financial Wellness; Support for Caregivers.
Additional info: Hybrid; work on-site in the U.S. and attend in-person events.
Pay: $206,000–$257,500 per year.
Applicants must be authorized to work in the U.S. (Apply if solution-oriented and comfortable with ambiguity/candor).
Responsibilities:
- Coordinate planning and execution of statistical deliverables with internal/external teams (e.g., CROs).
- Lead statistical modeling to support robust study designs and address statistical issues.
- Contribute to clinical protocol development (author/review Statistics section).
- Author/review statistical analysis plans (SAPs), ISS/ISE analyses, and shells for tables/figures/listings.
- Review CRF designs; design/specify randomization schedules and review test randomization lists.
- Provide statistical input to DMC/independent review charters and other study documents; review analysis dataset specifications.
- Perform QC/QA of statistical deliverables and validate key results.
- Conduct ad hoc/exploratory analyses beyond SAP; partner early with Clinical/Medical/Regulatory on scientific questions.
- Use modern tools (R, Python, interactive visualization apps) with SAS; maintain documentation/traceability.
- Support IND/NDA/MAA regulatory submissions; respond to FDA/regulatory comments and review IRB/EC comments.
- Contribute to clinical study reports, publications, and standardization/process improvements; mentor junior biostatisticians.
Qualifications:
- Ph.D. (strongly preferred) with 9+ years, or Master’s with 10+ years in statistics/related field (pharma/biotech).
- Demonstrated experience designing, analyzing, and reporting clinical trials.
- Knowledge of statistical methods (frequentist and Bayesian) and FDA/EMA/ICH guidelines.
- Proficient in SAS and R (Python/other languages a plus); EAST preferred.
- Working knowledge of SDTM/ADaM; ability to oversee CRO/contractor statistical services.
Desirable:
- Rare disease/gene therapy/neuromuscular experience; NDAs/MAAs; external control arms/RWE/observational methods.
Benefits (explicit): Physical and Emotional Wellness; Financial Wellness; Support for Caregivers.
Additional info: Hybrid; work on-site in the U.S. and attend in-person events.
Pay: $206,000–$257,500 per year.
Applicants must be authorized to work in the U.S. (Apply if solution-oriented and comfortable with ambiguity/candor).