Senior Biostatistician

Warman O'Brien; Manchester; Hybrid; GBP 50,000 - 75,000; Full time

Benefits offered by this job

Hybrid and flexible working

Job summary

Warman O'Brien is seeking an experienced Senior Statistician to join its UK-based biometrics team. The role offers remote or hybrid working and involves leading statistical activities across multiple trials, interacting with clients, and delivering high-quality outputs from study design to reporting.

You will coordinate statisticians and programmers, perform QC, and contribute to SAPs, study design, and regulatory submissions.

Qualifications

• Degree in Statistics or related quantitative field.
• 3+ years' experience as a Statistician in CRO/pharma/biotech.
• Experience leading statistical activities across trials and managing client-facing projects.
• Strong knowledge of ICH, regulatory guidance and CDISC standards (SDTM/ADaM).
• Advanced SAS programming with independent QC experience.

Responsibilities

• Lead SAP development, estimand strategies, and TLF shells.
• Coordinate statisticians and programmers to deliver SDTM/ADaM/TLF packages on time.
• Perform QC of datasets and analyses and validate complex ADaM datasets.
• Serve as primary statistical contact for clients throughout project lifecycles.
• Provide study design and sample size guidance; contribute to CTRs.
• Chair DRMs and document key decisions; support DMC/IDMC reporting.

Skills

Client interaction

Project leadership

Statistical analysis

Education

Degree in Statistics

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.