Director – Biostatistics – 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 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.
* Individual contributor role – NO line management
* 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.
Collaboration & Development:
* 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.
What to do next: If this opportunity is of interest, please apply now with your CV as the organisation are looking to welcome the new Statistician onboard as soon as possible.
Not what you are looking for? Please contact Aimee Weston at aimee@warmanobrien.com for a confidential discussion about potential opportunities.