Biostatistics Lead — Global Phase 3 Clinical Trials

Cytel; Olympia (WA); On-site; USD 150,000 - 210,000; Full time

Job summary

Cytel is seeking an Associate Director of Biostatistics dedicated to a major Pharma client, embedding within their team to lead or support Phase III trials using advanced statistical methods. You will collaborate with cross-functional stakeholders, oversee programming, and apply SAS/R to QC, analyses, and regulatory submissions, with emphasis on independent study leadership.

The role requires a Master’s in Statistics (PhD preferred) and 7+ years in pharma/biotech, with strong knowledge of

Qualifications

• Master’s degree in Statistics or related quantitative discipline; PhD preferred.
• 7+ years of experience supporting clinical trials in the pharmaceutical/biotech industry.
• ≥3 years experience in Phase II–III studies, including SAP development, sample size calculation, and TLF review.
• Strong knowledge of adaptive design, group sequential and statistical methods of count data.
• Prior experience in Hematology studies preferred.
• Understanding of the drug development process and end-to-end trial delivery.
• Working knowledge of EMA/FDA/ICH guidelines and regulatory expectations.
• Proficient in SAS and/or R for QC of outputs and collaboration with programming teams.
• Excellent communication skills and ability to interact with cross-functional stakeholders.
• Strong organizational and project management skills.

Responsibilities

• Lead statistical activities for assigned Clinical Trials (Phases 3) independently from protocol design to reporting of results.
• Represent Statistics function on cross-functional trial teams and collaborate effectively with all stakeholders.
• Oversight of internal programming activities and CRO contributions on trials.
• Contribute to or lead database lock, submission activities, safety reporting, and respond to regulatory questions.
• Collaborate with clinical, data management, and programming to finalize study outputs per regulatory requirements.
• Coordinate statistical activities across studies within the project ensuring alignment and on‑time delivery.

Skills

Statistical leadership

Cross-functional collaboration

Regulatory awareness

Project management

Communication excellence

Education

Master’s degree in Statistics or related quantitative discipline

PhD preferred

Tools

SAS

R

Job description

Cytel is seeking an Associate Director of Biostatistics dedicated to a major Pharma client, embedding within their team to lead or support Phase III trials using advanced statistical methods. You will collaborate with cross-functional stakeholders, oversee programming, and apply SAS/R to QC, analyses, and regulatory submissions, with emphasis on independent study leadership.

The role requires a Master’s in Statistics (PhD preferred) and 7+ years in pharma/biotech, with strong knowledge of