Director, Biostatistics — Lead Trial Strategy & Analysis

sarepta; Cambridge (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Sarepta seeks a Lead Study Statistician to take ownership of statistical strategy and execution for assigned clinical studies, from protocol development through database lock, data analysis, interpretation, and reporting.

As the program matures, you will advance to Program Statistical Lead, providing strategic statistical leadership across development stages and partnering with Clinical Development and senior leadership on key program decisions.

Qualifications

• 9+ years of hands-on clinical trial experience in pharma/biotech.
• Experience with adaptive trial designs, regulatory submissions, and cross-functional collaboration.
• Ability to develop statistical analyses in R and/or SAS and provide leadership to programming resources.
• Sponsor-side experience preferred.

Responsibilities

• Provide end-to-end statistical leadership for assigned clinical trials.
• Design endpoints, sample size, randomization, interim analyses.
• Lead adaptive trial design initiatives for development efficiency.
• Collaborate with cross-functional teams and senior leadership.
• Oversee regulatory submissions and interactions with agencies.
• Maintain hands-on expertise in R and SAS.

Skills

Statistical leadership

Hands-on clinical trials

Adaptive trial design

R and SAS programming

Tools

R

SAS

Job description

Sarepta seeks a Lead Study Statistician to take ownership of statistical strategy and execution for assigned clinical studies, from protocol development through database lock, data analysis, interpretation, and reporting.

As the program matures, you will advance to Program Statistical Lead, providing strategic statistical leadership across development stages and partnering with Clinical Development and senior leadership on key program decisions.