Executive Director, Biostatistics

Sarepta Therapeutics•Cambridge, MA

2d•$256,000 - $320,000•Hybrid

About The Position

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.

Requirements

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
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

Nice To Haves

Experience working in rare disease, gene therapy or siRNA modalities 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.

Responsibilities

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