Associate Director / Director, Biostatistics – Oncology
I’m partnering with a global pharmaceutical organisation seeking an experienced Oncology Biostatistician to join its development organisation at Associate Director or Director level.
This is a highly strategic individual contributor position for a statistician who combines deep technical expertise with the ability to influence clinical development strategy, regulatory interactions, and cross-functional decision-making across the full drug development lifecycle.
The hiring team is specifically looking for a statistical leader who can operate independently, provide scientific direction across multiple stakeholders, and remain hands-on with study design and methodology.
Key Responsibilities
- Define statistical strategy across clinical development programmes from early through late phase development
- Contribute to Target Product Profile (TPP) and Clinical Development Plan (CDP) development
- Serve as the lead statistical representative within cross-functional development teams
- Influence study design, endpoint strategy, interim analyses, and development decision-making
- Lead statistical input into regulatory interactions, briefing documents, submission strategies, and responses to health authority questions
- Support Go/No-Go decision frameworks using advanced statistical methodologies
- Design and oversee adaptive studies, simulations, modelling approaches, and innovative trial methodologies
- Provide strategic oversight of statistical deliverables across studies and submissions
- Present statistical recommendations and development strategies to senior leadership teams
- Collaborate closely with Clinical Development, Regulatory Affairs, Biometrics, Medical Affairs, Programming, Data Management, and external partners
- Mentor and guide statisticians across projects while driving best practice and scientific innovation
- Support biomarker, PK/PD, clinical and observational study programmes
- Contribute to publications, payer dossiers, regulatory submissions, and integrated evidence generation activities
Essential Requirements
- MSc or PhD in Biostatistics, Statistics, or a related quantitative discipline
- Significant experience within pharmaceutical development environments
- Oncology experience is mandatory
- Clinical Development experience is mandatory
- Regulatory submission experience is mandatory
- Experience supporting studies across multiple stages of drug development
- Strong understanding of clinical trial methodology and statistical strategy
- Experience working directly with cross-functional development teams
- Advanced knowledge of statistical methods applied to clinical and biomarker data
- SAS proficiency required
- R experience preferred
- Strong communication and stakeholder management skills
Ideal Background
The successful candidate will typically bring experience in:
- Early and late phase clinical development
- Adaptive trial design
- Bayesian methodologies
- Simulation modelling
- Interim analyses and data monitoring strategies
- Registrational studies and regulatory interactions
- Clinical Development Plans and programme-level strategy
- Statistical leadership across complex global programmes
- Influencing development decisions without direct line management responsibility
Candidates with a blend of pharmaceutical and CRO experience are welcome. However, candidates with exclusively CRO experience are unlikely to be suitable for this opportunity.
Location:
This role is UK home-based.
The position requires attendance at the Surrey office approximately once per quarter. Candidates will also be required to attend the office on their first day to collect equipment.
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