Senior Biostatistics Lead for Phase 3 Trials

Cytel; Columbia (SC); On-site; USD 140,000 - 210,000; Full time

Job summary

Cytel is seeking an Associate Director of Biostatistics to support a major pharma client, leading statistical activities for late-stage trials and shaping development plans. You will be embedded in the client team with Cytel providing backing and governance.

You will collaborate across cross-functional partners, oversee internal programming and CRO contributions, and apply adaptive designs, group sequential methods, and count data techniques to deliver regulatory-ready results.

Qualifications

• Master’s degree in Statistics or related quantitative discipline; PhD preferred.
• 7+ years of experience supporting clinical trials in the pharmaceutical/biotech industry.
• Solid recent experience (≥3 years) 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.

Responsibilities

• Lead statistical activities for assigned Clinical Trials (mainly Phases 3) independently from protocol design to reporting of results.
• Represent Statistics function on cross-functional trial teams and collaborate effectively with all cross-functional stakeholders.
• Oversight of internal programming activities and/or CRO contributions on assigned clinical trials and other activities.
• Contribute to or lead other activities from a statistical perspective as appropriate, including database lock and submission activities, safety reporting, adhoc requests and respond to regulatory questions.
• Collaborate closely with clinical, data management, programming, and other stakeholders to develop and finalize study outputs in line with regulatory and protocol requirements.
• Use SAS and/or R for purposes like QC of datasets and deliverables, inferential statistical analyses, modelling/simulation, exploratory analyses etc.
• Coordinate statistical activities across studies within the assigned project, ensuring alignment of objectives, consistency of approach, and on‑time delivery.

Skills

Communication skills

Cross-functional collaboration

Independence & ownership

Project management

Education

Master’s degree in Statistics

PhD preferred

Tools

SAS

R

Job description

Cytel is seeking an Associate Director of Biostatistics to support a major pharma client, leading statistical activities for late-stage trials and shaping development plans. You will be embedded in the client team with Cytel providing backing and governance.

You will collaborate across cross-functional partners, oversee internal programming and CRO contributions, and apply adaptive designs, group sequential methods, and count data techniques to deliver regulatory-ready results.