Senior Biostatistician

Warman O'Brien; Leeds; Hybrid; GBP 65,000 - 90,000; Full time

Benefits offered by this job

Hybrid working

Competitive salary

Professional development

Structured onboarding and training

Job summary

Warman O'Brien is seeking an experienced Senior Statistician to lead statistical activities across CRO projects in the UK. You will manage study design, estimand strategies, and statistical reporting while collaborating with clients and cross-functional teams to deliver high-quality outputs.

You will provide expert guidance, oversee SAP development, and coordinate with statisticians and programmers to ensure timely, regulatory-grade analyses and documentation.

Qualifications

• Lead statistical activities across multiple clinical projects and teams.
• Provide expert statistical guidance on study design, estimands and analysis plans.
• Oversee interpretation and reporting of clinical study results for regulatory submissions.
• Coordinate with clients and cross-functional teams to ensure timely, high-quality outputs.

Responsibilities

• Lead SAP development with estimand strategies and TLF shells.
• Coordinate statisticians and programmers to deliver SDTM/ADaM outputs.
• QC datasets and analyses with independent validation programming in SAS.
• Act as primary statistical contact for clients and provide consultancy on design and sample size.
• Chair DRMs and maintain thorough documentation for audits.

Skills

Statistical leadership

Clinical trial statistics

Stakeholder management

Study design

Education

Degree in Statistics or Biostatistics

Tools

SAS

Job description

Senior Statistician | UK | Remote | Mid-Size CRO | Permanent

Our client is an established specialist biometrics consultancy providing high-quality statistical and programming services to the pharmaceutical and biotechnology industry. Due to continued growth, they are seeking an experienced Senior Statistician to join their collaborative UK-based team.

This is an excellent opportunity for a statistician who enjoys combining technical expertise with client interaction, taking ownership of projects from study design through to reporting, while working on a diverse range of clinical development programmes.

The Role

As a Senior Statistician, you will provide statistical leadership across multiple clinical projects, working closely with clients and cross-functional teams to ensure the successful delivery of high-quality statistical outputs.

Key Responsibilities

• Lead the development of Statistical Analysis Plans (SAPs), including estimand strategies, statistical methodologies, hypothesis testing and mock table, listing and figure (TLF) shells.
• Coordinate statisticians and statistical programmers to deliver high-quality statistical outputs, including SDTM, ADaM and TLF packages, within agreed timelines.
• Perform quality control of datasets and statistical outputs, including independent validation programming of complex ADaM datasets and analyses using SAS.
• Serve as the primary statistical contact for clients, providing expert guidance throughout the lifecycle of clinical development projects.
• Provide statistical consultancy on study design, protocol development, sample size calculations and estimand strategies.
• Chair Data Review Meetings (DRMs), driving key decisions and ensuring appropriate documentation is maintained.
• Author and review statistical sections of Clinical Trial Reports (CTRs) and contribute to the interpretation and presentation of study results.
• Act as the independent statistician supporting Data Monitoring Committees (DMCs/IDMCs), including preparing reports and facilitating committee meetings.
• Manage project budgets, monitor project performance and initiate change orders where required.
• Support business development activities by participating in proposal development and Bid Defence Meetings.
• Represent the biometrics function during client audits and regulatory inspections where required.

About You

• Degree in Statistics, Biostatistics, Mathematics or a related quantitative discipline.
• Around three or more years' experience working as a Statistician within a CRO, pharmaceutical or biotechnology environment.
• Proven experience leading statistical activities across clinical trials and managing client-facing projects.
• Strong knowledge of ICH, regulatory guidance and CDISC standards, including SDTM and ADaM.
• Advanced SAS programming skills with experience performing independent quality control.
• Excellent communication and stakeholder management skills, with the ability to build strong client relationships.
• Highly organised, collaborative and committed to delivering high-quality work.

What's on Offer

• Competitive salary and comprehensive benefits package.
• Hybrid and flexible working arrangements.
• Supportive, collaborative culture with a flat organisational structure.
• Opportunity to work on varied and scientifically interesting clinical development programmes.
• Structured onboarding together with ongoing training and professional development.
• A genuine opportunity to influence projects, work closely with clients and continue developing your career within an expert biometrics environment.