Embedded Associate Director, Biostatistics — Phase 3 Trials

Cytel; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

Cytel is seeking an Associate Director of Biostatistics to lead statistical activities for Phases 3 trials embedded with major Pharma clients within our Global Therapeutic Statistics group.

In this role you will influence clinical development plans, protocols, and regulatory responses, using advanced methods, SAS and R, and overseeing vendor contributions. This position emphasizes independence, ownership, and impactful data-driven decisions.

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.
• Prior experience on Hematology studies preferred.
• Good understanding of the drug development process and cross-functional interfaces and experience supporting end-to-end trial delivery (from protocol input through CSR contributions).
• Working knowledge of EMA/FDA/ICH guidelines and regulatory expectations for clinical trials and submissions.
• Proficient in SAS and/or R for QC of statistical outputs and collaboration with programming teams.
• Excellent and effective communication skills and ability to interact effectively with cross-functional stakeholders and external partners.
• Strong organizational and project management skills.
• Demonstrated ability to work independently, take ownership and be accountable for study-level statistical activities and deliverables.

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 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

Project management

Independent work

Education

Master’s degree in Statistics or related quantitative discipline; PhD preferred

Tools

SAS

R

Machine learning

Deep learning

Job description

Cytel is seeking an Associate Director of Biostatistics to lead statistical activities for Phases 3 trials embedded with major Pharma clients within our Global Therapeutic Statistics group.

In this role you will influence clinical development plans, protocols, and regulatory responses, using advanced methods, SAS and R, and overseeing vendor contributions. This position emphasizes independence, ownership, and impactful data-driven decisions.