Executive Director, Biostatistics
Sarepta Therapeutics
August 08, 2026
Remote friendly (Pennsylvania, United States)
United States
Clinical Research and Development
Responsibilities:
- Provide strategic statistical leadership across a group of clinical development programs in DMD or the siRNA platform; drive regulatory-grade deliverables and hands-on exploratory analytics.
- Lead a Biometrics/Biostatistics team (biostatisticians, statistical programmers); be a hands-on biostatistician.
- Account for statistical/data aspects of clinical development plans, protocols, and regulatory submissions (or functional-level Biostatistics oversight).
- Oversee planning/execution of Biometrics deliverables (internal/external/CRO) meeting regulations and quality standards.
- Optimize statistical methods for study design, conduct, analysis, and reporting; address statistical issues.
- Lead statistical activities for IND/NDA/MAA submissions; prepare and respond to FDA/EMA/IRB/EC comments.
- Represent the company on statistical issues with regulators and partners; oversee vendors, KPIs, budgets/resources, and milestones.
- Develop SOPs; represent Biometrics/Biostatistics on cross-functional teams.
- Champion a confirmatory + fit-for-purpose exploratory “modern analytics” operating model; define governance/guardrails for exploratory work.
- Coach/mentor direct reports and junior team members.
Qualifications:
- PhD in statistics (15+ yrs) or Master’s (18+ yrs) in pharma/biotech.
- Senior leadership managing a team; deep expertise in clinical trial design/analysis/reporting.
- Biostatistics lead experience for NDAs/MAAs; extensive regulatory agency interaction; expert knowledge of frequentist & Bayesian methods.
- In-depth knowledge of FDA/EMA/ICH regulations.
- Programming: SAS and R (Python a plus); statistical design software (e.g., EAST).
- Experience with CRO outsourcing/management; communicate to non-scientists.
Preferred:
- Rare disease, gene therapy, or siRNA experience; immunology/gene therapy knowledge.
- External control arms, real-world data, causal inference; AI tools/workflows.
Benefits (as stated): physical/emotional wellness, financial wellness, caregiver support.
Application/Work location:
- Hybrid; work on-site in the U.S. at company facilities and attend in-person events as needed.
- Candidates must be authorized to work in the U.S.
- Apply if comfortable with ambiguity/candor and committed to patients.
- Provide strategic statistical leadership across a group of clinical development programs in DMD or the siRNA platform; drive regulatory-grade deliverables and hands-on exploratory analytics.
- Lead a Biometrics/Biostatistics team (biostatisticians, statistical programmers); be a hands-on biostatistician.
- Account for statistical/data aspects of clinical development plans, protocols, and regulatory submissions (or functional-level Biostatistics oversight).
- Oversee planning/execution of Biometrics deliverables (internal/external/CRO) meeting regulations and quality standards.
- Optimize statistical methods for study design, conduct, analysis, and reporting; address statistical issues.
- Lead statistical activities for IND/NDA/MAA submissions; prepare and respond to FDA/EMA/IRB/EC comments.
- Represent the company on statistical issues with regulators and partners; oversee vendors, KPIs, budgets/resources, and milestones.
- Develop SOPs; represent Biometrics/Biostatistics on cross-functional teams.
- Champion a confirmatory + fit-for-purpose exploratory “modern analytics” operating model; define governance/guardrails for exploratory work.
- Coach/mentor direct reports and junior team members.
Qualifications:
- PhD in statistics (15+ yrs) or Master’s (18+ yrs) in pharma/biotech.
- Senior leadership managing a team; deep expertise in clinical trial design/analysis/reporting.
- Biostatistics lead experience for NDAs/MAAs; extensive regulatory agency interaction; expert knowledge of frequentist & Bayesian methods.
- In-depth knowledge of FDA/EMA/ICH regulations.
- Programming: SAS and R (Python a plus); statistical design software (e.g., EAST).
- Experience with CRO outsourcing/management; communicate to non-scientists.
Preferred:
- Rare disease, gene therapy, or siRNA experience; immunology/gene therapy knowledge.
- External control arms, real-world data, causal inference; AI tools/workflows.
Benefits (as stated): physical/emotional wellness, financial wellness, caregiver support.
Application/Work location:
- Hybrid; work on-site in the U.S. at company facilities and attend in-person events as needed.
- Candidates must be authorized to work in the U.S.
- Apply if comfortable with ambiguity/candor and committed to patients.