Principal Lead Biostatistician - FSP - Oncology - 6509

PRINCIPAL STATISTICIAN Oncology | FSP | EMEA - Remote The opportunity An excellent opportunity has arisen for an experienced Principal Statistician to join a high-profile oncology programme through a dedicated functional service partnership. You will provide strategic statistical leadership across complex clinical trials, working closely with international clinical development, programming, data management and regulatory teams. This role would suit an autonomous, technically strong statistician who combines hands-on delivery with the confidence to influence programme strategy and communicate complex statistical concepts to both technical and non-technical stakeholders. Key responsibilities Provide strategic statistical leadership for the design, analysis and interpretation of complex oncology clinical trials, ensuring scientific rigour and regulatory compliance. Lead statistical input across study planning, protocol development, analysis strategy, interpretation and reporting. Oversee the quality and accuracy of statistical deliverables, including the review and quality control of SDTM datasets, analysis outputs and submission documentation. Drive the consistent application of CDISC standards, including SDTM and ADaM, across clinical programmes. Partner with clinical development, statistical programming, data management and regulatory colleagues to align statistical strategy with programme objectives. Translate complex statistical methodology and analytical findings into clear, decision-focused recommendations for clinical and non-statistical stakeholders. Contribute to regulatory submissions and support interactions with global health authorities, as required. Essential experience MSc or PhD in Biostatistics, Statistics or a closely related discipline. At least five years' relevant industry experience in a comparable statistical role. Strong oncology clinical-trial experience across multiple development phases, ideally Phase I–III. Advanced knowledge of clinical-trial design, statistical analysis and regulatory requirements. Extensive practical experience with CDISC standards, particularly SDTM and ADaM. Proficiency in SAS, with additional experience in R or other statistical software highly valued. A proven ability to work autonomously, lead statistical activities and resolve complex technical challenges proactively. Clear and confident written and verbal English, with the ability to engage and influence a varied international stakeholder group. Highly desirable Experience in haematological oncology indications such as multiple myeloma, leukaemia or lymphoma. Knowledge of advanced statistical methodologies and innovative trial designs used in oncology drug development. Previous involvement in NDA, BLA or other major regulatory submissions, including direct interaction with authorities such as the FDA or EMA. Experience supporting large, international clinical trials and coordinating across regions and functions. Location This is an EMEA-based opportunity. Applications are welcomed from candidates located in countries where the programme can engage and employ, subject to local eligibility and operational coverage. Interested? For a confidential discussion, please contact Aimee at aimee@warmanobrien.com.