Senior Director, Biostatistics
Sarepta Therapeutics
9 hours ago
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
The Importance of the Role
- Work with cross-functional teams to advance precision genetic medicines in DMD or siRNA platform.
- Provide statistical strategies for clinical development, regulatory submission, and patient access data generation.
- Own statistical aspects of clinical development plans/protocols/submissions; oversee regulatory-grade deliverables.
- Coordinate Biometrics/Biostatistics deliverables with internal/external teams (e.g., CROs) and ensure regulatory/quality compliance.
- Lead optimization of statistical methods (design, conduct, analysis, reporting); manage statistical issues.
- Support IND/NDA/MAA (or other) submissions; respond to FDA/EMA/regulators and IRB/EC comments.
- Develop/oversee SAPs, ISS/ISE, table/figure/listing shells; design randomization schedules and approve test randomization.
- Provide DMC input; conduct ad hoc/exploratory analyses.
- Author/oversee clinical study reports and support publications (manuscripts, posters, presentations).
- Lead team and champion modern confirmatory + exploratory analytics with governance guardrails; foster hands-on data exploration (R/Python/visualization + SAS).
More About You
- Ph.D. in statistics (11+ years) or Master’s (13+ years) in pharma/biotech.
- Statistical leadership for clinical development; clinical trial design/analysis/reporting.
- Experience with NDA/MAA or other regulatory submissions.
- Strong clinical trial methods (frequentist + Bayesian) and knowledge of FDA/EMA/ICH.
- Desirable: immunology/gene therapy; plus external control arms/real-world data/causal inference.
- SAS and R proficiency (Python/other plus); trial design software (e.g., EAST) plus.
- Knowledge of SDTM/ADaM; CRO oversight; communicate to non-scientists; manage Biostatistics/Biometrics team and resource planning.
Benefits (explicitly stated)
- Physical and Emotional Wellness; Financial Wellness; Support for Caregivers.
Application instructions
- Apply if you are solution-oriented, comfortable with ambiguity and candor, and lead with kindness and integrity.
- Work with cross-functional teams to advance precision genetic medicines in DMD or siRNA platform.
- Provide statistical strategies for clinical development, regulatory submission, and patient access data generation.
- Own statistical aspects of clinical development plans/protocols/submissions; oversee regulatory-grade deliverables.
- Coordinate Biometrics/Biostatistics deliverables with internal/external teams (e.g., CROs) and ensure regulatory/quality compliance.
- Lead optimization of statistical methods (design, conduct, analysis, reporting); manage statistical issues.
- Support IND/NDA/MAA (or other) submissions; respond to FDA/EMA/regulators and IRB/EC comments.
- Develop/oversee SAPs, ISS/ISE, table/figure/listing shells; design randomization schedules and approve test randomization.
- Provide DMC input; conduct ad hoc/exploratory analyses.
- Author/oversee clinical study reports and support publications (manuscripts, posters, presentations).
- Lead team and champion modern confirmatory + exploratory analytics with governance guardrails; foster hands-on data exploration (R/Python/visualization + SAS).
More About You
- Ph.D. in statistics (11+ years) or Master’s (13+ years) in pharma/biotech.
- Statistical leadership for clinical development; clinical trial design/analysis/reporting.
- Experience with NDA/MAA or other regulatory submissions.
- Strong clinical trial methods (frequentist + Bayesian) and knowledge of FDA/EMA/ICH.
- Desirable: immunology/gene therapy; plus external control arms/real-world data/causal inference.
- SAS and R proficiency (Python/other plus); trial design software (e.g., EAST) plus.
- Knowledge of SDTM/ADaM; CRO oversight; communicate to non-scientists; manage Biostatistics/Biometrics team and resource planning.
Benefits (explicitly stated)
- Physical and Emotional Wellness; Financial Wellness; Support for Caregivers.
Application instructions
- Apply if you are solution-oriented, comfortable with ambiguity and candor, and lead with kindness and integrity.