The opportunity

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

Interested?