Director Biostatistics

Director – Biostatistics (Asset Lead)- Oncology – Pharma – UK – Remote / Hybrid

We are seeking an experienced and highly skilled Biostatistics Director to join a cross‑functional team in a leading global pharmaceutical environment. This role requires strong independent leadership to support clinical and observational studies, medical affairs strategies, biomarker and PK/PD analyses, or regional projects.

The Director may also lead statistical efforts for early‑stage assets or late‑stage, or serve as a methodology expert, ensuring high‑quality data analysis and interpretation across a variety of programs.

Key Responsibilities

• Serve as lead statistician for complex studies, including early- or late-phase clinical trials, observational research, and biomarker analysis.
• Provide strategic statistical input into study designs, development plans, and decision-making processes.
• Guide and deliver high-quality statistical outputs and ensure consistency across projects.
• Execute and support biomarker and PK/PD strategies.
• Will be mentoring study level statisticians working on the trials.
• Prepare and review statistical content for regulatory submissions, payer dossiers, and scientific publications.
• Clearly present data and findings to stakeholders, including study teams and leadership.
• Ensure integrated databases and external data sources are available to support analysis for submissions or marketing purposes.
• Participate in due diligence activities, data review, and provide expert statistical advice.
• Implement and validate advanced statistical methods and provide methodological oversight.
• Identify and resolve statistical issues that may impact data integrity or development decisions.
• Contribute to improvements in systems, processes, and standards related to statistical practices and outputs.
• Support recruitment, mentorship, and development of statistical staff.
• Participate in external professional networks and collaborate with academic and industry partners on innovative methods.

Required Qualifications

• PhD or Master’s degree in Biostatistics, Statistics, or a related scientific discipline.
• Minimum 6 years of relevant experience with a PhD (9+ years with a Master’s degree), ideally in pharmaceuticals, CROs, academia, or healthcare.
• Deep knowledge of statistical methods, with proven ability to analyze clinical and biomarker data.
• Proficient in SAS; knowledge of R is preferred.
• Strong understanding of data management and programming practices.
• Experience working across international teams.
• Familiarity with clinical development, regulatory requirements, and medical literature.
• Ability to explain and implement complex statistical methodologies effectively.

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