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 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 WellnessSupport for CaregiversFor a full list of our comprehensive benefits, see our website: The Importance of the Role 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. It is an excellent opportunity to work at the forefront of precision genetic medicine, making an impact on the development of transformative therapies that may change the lives of patients. The ideal candidate is a good communicator, high-energy, self-motivated, and forward thinking. Experience working in rare disease is desirable, but not required.The Opportunity to Make a Difference Lead collaboration with internal and external (e.g., CRO) team members to coordinate the planning and execution of statistical deliverablesLead/conduct statistical modeling to enable robust and efficient statistical designs and to address identified or potential statistical issues arising in studies or programsContribute to clinical protocol development, including authoring of the Statistics section and reviewing of other sections by applying statistical principlesAuthor or review statistical analysis plans for clinical trials and for integrated summaries of safety/effectiveness (ISS/ISE), and author or oversee the development of shells for tables, figures and listingsReview case report form (CRF) designs to ensure data collection meets the requirements of statistical analysesDesign and specify randomization schedules; review and approve test randomization listsProvide statistical input to data monitoring committee (DMC) charters, independent review charters, and other study-level documentsReview analysis dataset specificationsPerform QC/QA of statistical deliverables including validation of key analysis resultsPerform ad hoc and exploratory statistical analyses as neededContribute to clinical study reports, including authoring of statistical methods and interpretation of the study resultsBe accountable for assigned statistical activities in support of IND/NDA/MAA or other regulatory submissionsAddress statistical questions/comments from FDA and other regulatory agencies, and review and address comments by IRB/ECsSupport and contribute to the preparation of publications, including manuscripts, posters and oral presentationsContribute or lead standardization and process improvement efforts for Biostatistics and contribute to cross-functional process improvement effortsRepresent Sarepta regarding statistical issues in meetings with external parties including regulatory agencies and corporate partnersServe as a mentor to junior team membersConduct hands-on exploratory analyses beyond pre-specified SAP deliverables, probing unexpected results, testing sensitivity scenarios, and generating rapid insights to inform program decisionsPartner proactively with Clinical, Medical, and Regulatory colleagues to identify and prioritize scientific questions that warrant exploratory investigation, bringing Biometrics perspective early, not only at the analysis stageLeverage modern analytical tools (R, Python, interactive visualization apps) alongside SAS to accelerate data-to-insight timelines, while maintaining clear documentation and traceability of exploratory workContribute 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 useMore about You 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 industryDemonstrated ability and experience in the design, analysis, and reporting of clinical trialsExperience in NDAs, MAAs or other regulatory submissions preferredIn-depth knowledge of statistical methods for clinical trials, including both frequentist and Bayesian approachesIn-depth knowledge of FDA, EMA, and ICH regulations and guidelinesKnowledge of gene therapy, rare disease, or neuromuscular diseases is desirable, but not requiredProficient in statistical programming in SAS and R; Python and other languages a plusProficient in statistical design software such as EASTAbility to concurrently lead statistical efforts for multiple studiesUnderstanding of data standards, including SDTM and ADaMAbility to oversee statistical services provided by CROs and/or contractorsAbility to work independently, guide team and junior biostatisticians, and act with initiative to address issuesAbility to collaborate effectively with colleagues from all other functionsExcellent written and oral communication skills, including the ability to effectively communicate statistical concepts in a clear and concise mannerFamiliarity with external control arms, real-world evidence, or observational study methods is a plusWillingness and ability to perform hands-on data exploration using R and/or Python, in addition to SASEnthusiasm for learning and harnessing modern AI tools and workflows to enhance analytical productivity and scientific insightDemonstrated experience partnering with clinical development teams to shape analytical strategy, not just execute pre-defined plansWhat 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-HybridThis 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 $206,000 - $257,500 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.SummaryLocation: Cambridge, MA; Remote Maryland; Remote Maine; Remote Washington DC; Remote South Carolina; Remote Delaware; Remote Connecticut; Remote Illinois; Remote Pennsylvania; Remote Ohio; Remote North Carolina; Remote New Jersey; Remote Virginia; Remote Massachusetts; Remote Vermont; Remote California; Remote Rhode Island; Remote New York; Remote New HampshireType: Full time