Director, Biostatistics

SAREPTA

. Serve as Lead Study Statistician for assigned clinical studies from protocol development through database lock, data analysis, interpretation, and reporting .

Posted 9/22/2026full-timeCambridge • Massachusetts • United StatesLead💰 $206,000 - $257,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in statistical design and analysis for clinical trials, including adaptive designs and regulatory submissions. Proven ability to lead cross-functional collaborations and mentor statistical teams while ensuring compliance with GCP and regulatory standards.

Highest-signal resume keywords

Ph.D. In Statistics/BiostatisticsClinical Trial DesignStatistical Programming In R/SASRegulatory Submissions ExperienceStatistical Methodology Expertise

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical AnalysisAdaptive Trial DesignsSample Size DeterminationRandomizationInterim AnalysesMultiplicityEstimandsSensitivity AnalysesSubgroup AnalysesStatistical Standards Development

Soft Skills

Excellent Written CommunicationExcellent Verbal CommunicationCross-Functional CollaborationIndependent Decision-MakingPrioritization Skills

Tools & Technologies

RSASStatistical Programming ToolsAI Tools and Workflows

Industry Keywords

Clinical DevelopmentGCPRegulatory GuidanceBiotechnology IndustryPharmaceutical Industry

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Serve as Lead Study Statistician for assigned clinical studies from protocol development through database lock, data analysis, interpretation, and reporting
Own statistical strategy and execution for assigned clinical trials
Progressively assume responsibility as Program Statistical Lead across studies and development stages
Partner with Clinical Development and senior leadership on key program decisions, pivotal study strategy, integrated analyses, and regulatory strategy
Lead statistical design of clinical trials, including endpoint strategy, sample size, randomization, interim analyses, and methodological considerations
Evaluate, implement, and interpret adaptive trial designs
Provide statistical leadership and hands-on support for regulatory submissions, including pivotal analyses, submission documents, analysis datasets, and responses to regulatory inquiries
Lead or contribute to statistical discussions with FDA, EMA, and other health authorities
Collaborate with Clinical Development, Clinical Operations, Data Management, Medical, Regulatory, Statistical Programming, and other functions
Provide statistical oversight and direction to CROs and external vendors
Develop, review, troubleshoot, and validate statistical analyses, outputs, and documentation in R and/or SAS
Provide technical oversight of statistical programming and analysis datasets
Develop statistical standards, best practices, processes, and capabilities
Mentor and develop statisticians and statistical programmers
Contribute to hiring, resource planning, and team growth

Requirements

What you’ll need

Ph.D. (strongly preferred) in Statistics / Biostatistics with 9+ years of experience, or a Master’s degree in Statistics / Biostatistics with 10+ years of progressive biostatistics experience in the pharmaceutical or biotechnology industry
At least 8 years of substantial, direct clinical trial experience
Sponsor-side experience and ownership of clinical development studies; CRO/vendor-only experience does not meet the core requirement
Experience with clinical trial design, including adaptive trial designs
Experience with statistical analysis and regulatory submissions
Experience interacting directly with cross-functional clinical development teams
Expertise in clinical trial methodology and statistical principles, including adaptive designs, sample size determination, randomization, interim analyses, multiplicity, estimands, missing data, sensitivity analyses, and subgroup analyses
Hands-on statistical programming skills in R and/or SAS
Experience developing and reviewing SAPs, TFL specifications, integrated analyses, CSRs, and regulatory submission materials
Strong understanding of GCP and applicable statistical and regulatory guidance
Excellent written and verbal communication skills
Ability to work effectively in a cross-functional, collaborative environment
Ability to operate independently, prioritize competing demands, and make sound statistical decisions with limited supervision
Enthusiasm for learning and harnessing modern AI tools and workflows
Must be authorized to work in the U.S.

Benefits

Comp & perks

Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
Competitive compensation and benefit package
Work-life resources supporting integration of work and personal lives
Hybrid work arrangement
Company-sponsored in-person events