Principal Lead Biostatistician (Biomarkers) - 6284

Lead Biostatistician -CRO / FSP Opportunity | Leading Biotechnology Client | UK/EU (Remote) Our client, a globally recognised CRO, is seeking a Lead Biostatistician to join a dedicated Functional Service Provider (FSP) team supporting a leading biotechnology organisation focused on developing innovative therapies for patients with significant unmet medical needs. This position offers the opportunity to work as an integrated member of the client's Quantitative Sciences function, contributing directly to clinical development strategy and the successful delivery of global development programmes. The Role As Lead Biostatistician, you will provide strategic statistical expertise across clinical studies and development programmes, supporting critical decisions from study design through to regulatory submission. Working within a highly collaborative and multidisciplinary environment, you will partner closely with clinical development, regulatory affairs, data management, programming, and medical teams to ensure the delivery of scientifically robust and regulatory-compliant statistical solutions. Key Responsibilities Provide statistical leadership for clinical trials and development programmes. Contribute to study design, protocol development, sample size calculations, and statistical methodology. Author and review statistical analysis plans, study reports, and regulatory submission documents. Lead the interpretation and communication of statistical results to key stakeholders. Support interactions with regulatory authorities and health agencies. Ensure statistical activities are delivered to the highest scientific and regulatory standards. Collaborate effectively across global, cross-functional teams. Candidate Profile Essential Requirements MSc or PhD in Statistics, Biostatistics, Mathematics, or a related quantitative discipline. Minimum 8 years of industry experience in biostatistics within biotechnology, pharmaceutical, or CRO settings. Strong understanding of clinical development and biostatistical methodologies across all phases of clinical research. Demonstrated experience leading statistical activities across multiple clinical studies. Experience supporting biomarker strategy, biomarker analyses, and biomarker-driven clinical development. Advanced programming expertise in SAS and/or R. Practical experience developing analytical applications and visualisation tools using R Shiny. Strong communication skills with the ability to explain complex statistical concepts to diverse audiences. Proven ability to work independently while building effective relationships with internal and external stakeholders. Additional Requirements Comfortable working within an FSP model as an embedded partner to the client organisation. Open to periodic travel and onsite collaboration at the client's offices in, Belgium. What's on Offer This opportunity provides the best of both worlds: the stability, resources, and career development opportunities of a global CRO, combined with the scientific innovation, pace, and visibility of working directly with a leading biotechnology company. You will have the opportunity to make a meaningful impact on clinical development programmes while collaborating with industry-leading experts in a dynamic and highly innovative environment. To learn more about this opportunity, please submit your application or contact me at aimee@warmanobrien.com for a confidential discussion.