Executive Director, Biostatistics

Why Sarepta Why Now

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 2023 we launched our fourth therapy and the first ever gene therapy to treat Duchenne.

Were looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.

What Sarepta Offers

At Sarepta we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:

• Physical and Emotional Wellness

• Financial Wellness

• Support for Caregivers
  

For a full list of our comprehensive benefits see our website: Importance of the Role

The Opportunity to Make a Difference

The Opportunity to Make a Difference

• Be accountable for all statistical and data aspects of an assigned group of clinical development programs including clinical development plans protocols and regulatory submissions or be responsible for assigned areas of Biostatistics functional-level oversight
• Oversee the planning and execution of Biometrics or Biostatistics deliverables from internal and external teams (e.g. CRO) that meet their objectives while complying with regulations and quality standards
• Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives
• Oversee optimization of statistical methods for the design conduct analysis and reporting of clinical studies and to address identified or potential statistical issues arising in studies or programs
• Oversee planning and execution of statistical activities in support of IND/NDA/MAA or other regulatory submissions while maintaining an active role in cross-functional strategies and preparation of regulatory submissions
• Address statistical questions/comments from FDA EMA and other regulatory agencies and review and address comments by IRB/ECs
• Represent Sarepta regarding statistical issues with external parties including regulatory agencies and corporate partners
• Oversee vendors with respect to key performance indicators metrics and key deliverables and timelines
• Oversee project budget/resource planning re-forecasting and milestones along with other functions
• Lead or participate in development and implementation of functional or cross-functional SOPs for process simplification standardization or improvement
• Represent Biometrics or Biostatistics in cross-functional teams or committees
• Champion a modern analytics operating model that pairs pre-specified confirmatory analyses with fit-for-purpose exploratory analytics enabling the team to interrogate data rapidly while maintaining regulatory defensibility
• Partner closely with Clinical Development Medical Affairs and Regulatory to translate emerging scientific questions into actionable exploratory analysis plans ensuring Biometrics is embedded in decision-making not just reporting
• Lead rapid-response analytical efforts (e.g. post-readout deep dives ad-hoc regulatory queries) with clear scientific triage prioritization and interpretation under compressed timelines
• Define governance guardrails for exploratory work including risk-based validation documentation standards and clear separation from submission-quality deliverables so the team can move fast without creating compliance debt
• Foster a culture where biostatisticians are hands-on analysts and scientific architects not solely oversight managers personally engaging with data exploration using modern tools (R Python interactive visualization) alongside traditional SAS workflows
• Be responsible for coaching mentoring and performance management of direct reports
• Serve as a mentor to junior managers and team members

More about You

More about You

• Ph.D. in statistics or related discipline with 15 years or Masters Degree with 18 years of experience in the pharmaceutical or biotech industry
• Proven track record in a senior leadership role managing a team
• Demonstrated statistical leadership for clinical development and ability and experience in effectively contributing to clinical development plans
• Demonstrated expertise in the design analysis and reporting of clinical trials
• Experience as Biostatistics lead for NDAs MAAs or other regulatory submissions
• Extensive experience of interactions with regulatory agencies
• In-depth knowledge of statistical methods for clinical trials including both frequentist and Bayesian approaches
• Demonstrated ability and experience in unconventional statistical work to address questions or objectives arising from clinical research and drug development
• In-depth knowledge of FDA EMA and ICH regulations and guidelines
• Knowledge of immunology and/or gene therapy is desirable but not required
• Experience with external control arms real-world data or causal inference methods is a plus
• Proficient in statistical programming in SAS and R; Python and other languages a plus
• Proficient in statistical design software (e.g. EAST)
• Adept at outsourcing and managing biostatistical services provided by CROs and/or contractors
• Ability to communicate statistical information to non-scientists willingness to educate internal team
• Extensive experience in managing a Biostatistics or Biometrics team and overall resource planning
• Demonstrated ability and experience in driving Biostatistics or Biometrics functional goals in alignment with corporate goals
• Comfort operating in a dual-track model: formal SAP-driven analyses alongside agile hypothesis-driven exploration
• Enthusiasm for harnessing modern AI tools and workflows and willingness to champion their responsible adoption across the Biometrics team
• Track record of partnering with clinical development teams as a strategic thought partner not just a service function

What Now

Were always looking for solution-oriented critical thinkers.

So if youre comfortable with ambiguity and candor relish challenging yourself and place kindness and integrity at the forefront of how you approach your peers and work then we encourage you to apply.

What Now

Were always looking for solution-oriented critical thinkers.

So if youre comfortable with ambiguity and candor relish challenging yourself and place kindness and integrity at the forefront of how you approach your peers and work then we encourage you to apply.