Director, Biostatistics

📋 Description

• Lead statistical strategy for programs from design to regulatory submission.
• Serve as statistical lead and partner to cross-functional teams and CROs.
• Design/oversee robust trial designs balancing rigor with feasibility.
• Oversee protocols, SAPs, tables/listings/figures, and study reports.
• Mentor statisticians; foster professional growth and regulatory compliance.
• Travel to Cambridge, MA and other locations several times per year.

🎯 Requirements

• PhD in Statistics/Biostatistics or related field with 10+ yrs; or MSc with 14+ yrs in clinical trials.
• SAS or R programming; advanced analyses and simulations; CDISC standards.
• Experience designing trials Phases I-III; regulatory alignment.
• Experience in analysis and reporting; ISS and ISE.
• Experience with regulatory authorities is a plus.
• Excellent communication, negotiation and organizational skills; able to work independently.

🎁 Benefits

• Remote work opportunities within the United States.
• Occasional travel to Cambridge, MA for company events.
• Accommodations available for candidates in the selection process.
• Equal Opportunity Employer; inclusive environment.