Executive Director, Biostatistics at Sarepta Therapeutics

Cambridge, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

19 Sep, 26

Salary

320000.0

Posted On

21 Jun, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Biostatistics, Clinical Development Strategy, Regulatory Submissions, SAS, R, Python, Bayesian Approaches, Frequentist Statistics, CRO Management, Clinical Trial Design, Resource Planning, People Management, Data Exploration, EAST Software, Causal Inference, Real-World Data

Industry

Biotechnology Research

Description

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 diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne. We’re 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: https://www.sarepta.com/join-us The Importance of the Role The Importance of the Role This individual will provide strategic statistical leadership across a group of clinical development programs in DMD or the siRNA platform. The role requires a leader who can operate across both confirmatory and exploratory analytics — driving rigorous regulatory-grade deliverables while fostering a culture of rapid, hands-on data exploration in close partnership with clinical development. The ideal candidate must lead a Biometrics team comprising biostatisticians and statistical programmers and excel as a hands-on innovative biostatistician. They will be recognized as an influential leader across the organization and externally, shaping clinical development strategy — not solely executing within it. The ideal candidate will be a strategic thinker, a good communicator, high-energy, self-motivated, and forward thinking. Experience working in rare disease, gene therapy or siRNA modalities is desirable, but not required. 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 Master's 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? We're always looking for solution-oriented, critical thinkers. So, if you're 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? We’re always looking for solution-oriented, critical thinkers. So, if you’re 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. #LI-Hybrid This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time. The targeted salary range for this position is $256,000 - $320,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. Candidates must be authorized to work in the U.S. Sarepta Therapeutics offers a competitive compensation and benefit package. Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify. Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. 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. Our deep pipeline is driven by our multi-platform technologies in siRNA, RNA and gene therapy. For more information, please visit www.sarepta.com or follow us on Twitter, LinkedIn, Instagram and Facebook.

Responsibilities

Provide strategic statistical leadership for clinical development programs, overseeing biometrics deliverables and regulatory submissions. Lead a team of biostatisticians and programmers while partnering with cross-functional teams to translate scientific questions into actionable analysis plans.