Director, Biostatistics

Why Sarepta?

The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases.

Sarepta cares deeply about all the people in our community and believes in the importance of supporting them in all aspects of their lives. We strive to help everyone integrate their work and personal lives while maintaining productivity, offering a range of physical and emotional wellness, financial wellness, and support for caregivers.

The person in this position will be working with a cross‑functional team as the project biostatistician responsible for statistical activities at the compound level or study level in DMD or siRNA platforms. Beyond traditional SAP‑driven deliverables, this role calls for a hands‑on analyst who can explore data deeply, partner with clinical development to shape scientific questions, and deliver rapid insights using modern analytical tools.

• Lead collaboration with internal and external team members to coordinate the planning and execution of statistical deliverables
• Lead/conduct statistical modelling to enable robust and efficient statistical designs and to address identified or potential statistical issues arising in studies or programs
• Contribute to clinical protocol development, including authoring the Statistics section and reviewing other sections by applying statistical principles
• Author or review statistical analysis plans for clinical trials and integrated summaries of safety/effectiveness (ISS/ISE), and oversee the development of shells for tables, figures and listings
• Review case report form (CRF) designs to ensure data collection meets the requirements of statistical analyses
• Design and specify randomisation schedules; review and approve test randomisation lists
• Provide statistical input to data monitoring committee (DMC) charters, independent review charters, and other study‑level documents
• Review analysis dataset specifications
• Perform QC/QA of statistical deliverables including validation of key analysis results
• Perform ad hoc and exploratory statistical analyses as needed
• Contribute to clinical study reports, including authoring statistical methods and interpretation of the study results
• Be accountable for assigned statistical activities in support of IND/NDA/MAA or other regulatory submissions
• Address statistical questions/comments from FDA and other regulatory agencies, and review and address comments by IRB/ECs
• Support and contribute to the preparation of publications, including manuscripts, posters and oral presentations
• Contribute or lead standardisation and process improvement efforts for Biostatistics and cross‑functional process improvement efforts
• Represent Sarepta regarding statistical issues in meetings with external parties including regulatory agencies and corporate partners
• Serve as a mentor to junior team members
• Conduct hands‑on exploratory analyses beyond pre‑specified SAP deliverables, probing unexpected results, testing sensitivity scenarios, and generating rapid insights to inform program decisions
• Partner proactively with Clinical, Medical, and Regulatory colleagues to identify and prioritise scientific questions that warrant exploratory investigation, bringing the biometrics perspective early, not only at the analysis stage
• Leverage modern analytical tools (R, Python, interactive visualisation apps) alongside SAS to accelerate data‑to‑insight timelines, while maintaining clear documentation and traceability of exploratory work
• Contribute to fit‑for‑purpose validation practices, distinguishing between outputs intended for internal learning versus those that require production‑grade validation for external communication or regulatory use

• Ph.D. (strongly preferred) with 9+ years or Master’s degree with 10+ years of experience in statistics or related discipline in the pharmaceutical or biotech industry
• Demonstrated ability and experience in the design, analysis, and reporting of clinical…