Senior Biostatistics Lead - Embedded Phase 3 Trials

Cytel; United Kingdom; On-site; GBP 90,000 - 130,000; Full time

Job summary

Cytel in the United Kingdom seeks an Associate Director of Biostatistics to be embedded with a major Pharma client within Cytel's Global Therapeutic Statistics group. Lead statistical activities for clinical trials, from protocol design to reporting of results, and influence development plans and regulatory submissions.

The role requires a PhD or equivalent, 7+ years of industry experience, and strong SAS/R skills.

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 communication skills and ability to interact with cross-functional stakeholders and external partners.
• Strong organizational and project management skills.
• Demonstrated ability to work independently, own and deliver study-level statistics.

Responsibilities

• Lead statistical activities for assigned Clinical Trials (mainly Phases 3) from protocol design to reporting of results.
• Represent Statistics on cross-functional trial teams and collaborate with stakeholders.
• Oversee internal programming activities and CRO contributions.
• Contribute to or lead activities such as database lock, submissions, safety reporting and regulatory inquiries.
• Collaborate with clinical, data management, programming and other stakeholders to finalize study outputs per regulatory requirements.
• Use SAS and/or R for QC, analyses, modelling and exploratory work.
• Coordinate statistical activities across studies within a project to ensure alignment and on-time delivery.

Skills

7+ years experience

SAS

R

Adaptive design

Group sequential design

Pharma/biotech experience

Communication skills

Project management

Independence & ownership

Education

Master’s degree in Statistics

PhD preferred

Tools

SAS

R

Job description

Cytel in the United Kingdom seeks an Associate Director of Biostatistics to be embedded with a major Pharma client within Cytel's Global Therapeutic Statistics group. Lead statistical activities for clinical trials, from protocol design to reporting of results, and influence development plans and regulatory submissions.

The role requires a PhD or equivalent, 7+ years of industry experience, and strong SAS/R skills.