Job Title: Senior Biostatistician I – (with Programming Support)
Location: (Remote - United Kingdom)
About the Role:
We are seeking a Senior Biostatistician to join an embedded team in a CRO. This role is primarily focused on biostatistical design, analysis, and reporting for clinical trials, while also requiring hands-on programming support (SAS/R) as the team integrates both functions.
You will play a key role in ensuring the statistical integrity and quality of clinical trial deliverables, working closely with cross-functional teams including programmers, data managers, and project managers. This is an ideal role for someone who wants to remain hands-on with biostatistics while also contributing to programming and reporting tasks.
Key Responsibilities:
• Lead statistical planning and analysis for clinical trials, including efficacy, safety, and exploratory endpoints.
• Develop and implement statistical analysis plans (SAPs) and contribute to study design discussions, including sample size calculations, randomization, and stratification strategies.
• Program and validate statistical outputs using SAS or R, including tables, listings, and figures (TLFs) for study reports and regulatory submissions.
• Ensure all statistical and programming deliverables comply with regulatory standards (ICH-GCP, FDA/EMA guidelines) and internal quality requirements.
• Collaborate closely with other biostatisticians and programmers within the same team to ensure consistent and high-quality study deliverables.
• Act as the primary statistical resource for assigned studies while providing support for programming tasks as needed.
• Support client engagement, providing statistical input and guidance on study deliverables, while reporting internally for professional development and support.
Requirements:
• Proven experience as a biostatistician in clinical trials, ideally at Senior I / early Senior II level.
• Strong programming skills in SAS and/or R, with the ability to produce and validate outputs independently.
• In-depth knowledge of clinical trial design, statistical methodology, and regulatory requirements.
• Experience in FSP or embedded client roles is advantageous.
• Self-motivated, detail-oriented, and comfortable working both independently and as part of a cross-functional, integrated statistics/programming team.
[email protected]
Salary: GBP 36000 - 60000 per year
Experience: 5 years required