Senior Director, Biostatistics

Sarepta Therapeutics•Cambridge, MA

14h•Hybrid

About The Position

This individual will work with cross-functional teams to advance transformative precision genetic medicines in DMD or 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 be able to lead a Biometrics team comprising biostatisticians and statistical programmers and excel as a hands-on innovative biostatistician. The ideal candidate will be a strategic thinker, a good communicator, high-energy, self-motivated, and forward thinking. Experience working in rare disease or gene therapy is desirable, but not required.

Requirements

Ph.D. in statistics or related discipline with 11+ years, or Master’s Degree with 13+ years of experience in the pharmaceutical or biotech industry
Experience of providing statistical leadership for clinical development programs
Demonstrated ability and experience in the design, analysis and reporting of clinical trials
Experience leading NDAs, MAAs or other regulatory submissions
In-depth knowledge of statistical methods for clinical trials, including both frequentist and Bayesian approaches
Knowledge of FDA, EMA and ICH regulations and guidelines
Proficient in statistical programming in SAS and R
Experience with trial design software (e.g., EAST)
Ability to concurrently lead or coordinate statistical efforts for multiple projects
Understanding of data standards, including SDTM and ADaM
Adept at overseeing statistical services provided by CROs
Ability to communicate statistical information to non-scientists, willingness to educate internal team
Experience in managing a Biostatistics or Biometrics team and overall resource planning
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

Nice To Haves

Experience working in rare disease or gene therapy is desirable, but not required.
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
Python and other languages a plus

Responsibilities

Provide statistical strategies and expertise for clinical development, regulatory submission, and patient access data generation for the assigned clinical development program or functional areas
Be accountable for all statistical aspects of assigned clinical development programs or functional area, including clinical development plans, protocols and regulatory submissions
Oversee collaboration with internal and external (e.g., CRO) team members to coordinate 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 members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives
Lead/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
Be accountable for statistical activities in support of IND/NDA/MAA or other regulatory submissions
Address statistical questions/comments from FDA, EMA, and other regulatory agencies, and review and address comments by IRB/ECs
Author or oversee the development of statistical analysis plans for clinical trials and for integrated summaries of safety/effectiveness (ISS/ISE), and oversee the development of shells for tables, figures, and listings
Represent Sarepta regarding statistical issues with external parties including regulatory agencies and corporate partners
Contribute to clinical protocol development, including authoring of the Statistics section and reviewing of other sections by applying statistical principles
Review case report form (CRF) designs to ensure data collection meets the requirements of statistical analyses
Design and specify randomization schedules; review and approve test randomization lists
Provide statistical input to data monitoring committee (DMC) charters, independent review charters, and other study-level documents
Perform ad hoc and exploratory statistical analyses as needed
Contribute to clinical study reports, including authoring of statistical methods and interpretation of the study results
Support and contribute to the preparation of publications, including manuscripts, posters and oral presentations
Contribute or lead standardization and process improvement efforts for Biometrics and contribute to cross-functional process improvement efforts
Participate in development and implementation of functional or cross-functional SOPs for process simplification, standardization or improvement
Develop and lead a team of high performing biostatisticians to meet corporate, R&D, and program goals
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