Associate Director, Biostatistics — Phase 3 Trial Leader

Cytel; Boston (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Cytel is seeking an Associate Director of Biostatistics to work embedded with a major Pharma client in Boston. You will lead statistical activities from design through reporting, ensuring regulatory alignment and high-quality analyses. You will collaborate with cross-functional teams and oversee vendor contributions to trials.

The role emphasizes expertise in Phase II-III analyses, adaptive design and interaction with regulatory bodies, with SAS/R proficiency and strong communication skills.

Qualifications

• Master’s degree in Statistics or related quantitative discipline; PhD preferred.
• 7+ years of experience supporting clinical trials in pharma/biotech.
• Solid recent experience in Phase II-III studies, including SAP development, sample size calculation, and TLF review.
• Working knowledge of EMA/FDA/ICH guidelines and regulatory expectations.

Responsibilities

• Lead statistical activities for assigned Clinical Trials (Phases 3) from protocol design to reporting.
• Represent Statistics on cross-functional trial teams and collaborate with stakeholders.
• Oversee internal programming activities and CRO contributions on trials.
• Contribute to database lock and submission activities, safety reporting, and regulatory responses.
• Develop and finalize study outputs in line with regulatory and protocol requirements.

Education

Master’s degree in Statistics

PhD preferred

Tools

SAS

R

Job description

Cytel is seeking an Associate Director of Biostatistics to work embedded with a major Pharma client in Boston. You will lead statistical activities from design through reporting, ensuring regulatory alignment and high-quality analyses. You will collaborate with cross-functional teams and oversee vendor contributions to trials.

The role emphasizes expertise in Phase II-III analyses, adaptive design and interaction with regulatory bodies, with SAS/R proficiency and strong communication skills.