Senior Biostatistician I

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.eireann.evans@

Created: 2025-10-11