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Director, Regulatory Data

1 month ago

United Kingdom Warman O'Brien Full time

Director Biostatistics | Global Pharma | UK | Home Based |
Global Pharma recognised for its commitment to innovation and patient impact, is expanding rapidly in the UK. As part of this growth, the company is offering a rare opportunity for a Director Biostatistics to join them.

And every project pushes the boundaries of what’s possible in modern medicine.

As a Director Biostatistics you will be joining a cross-functional team that 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.

Lead statistical strategy for haematology oncology, serving as compound-level statistical lead across development, evidence generation, and regulatory/payer interactions.
Provide cross-functional leadership across clinical, medical affairs, RWE, safety, and biomarker statistics.
Represent the organisation in global regulatory and payer discussions (FDA, EMA, PMDA, HTA), guiding statistical input for submissions and evidence packages.
Act as an individual contributor (no line management) while mentoring study-level statisticians.
Ensure integrated data availability for submissions and marketing support.
Contribute to due diligence, data review, and expert statistical guidance.
PhD or Master’s in Biostatistics, Statistics, or related field.
Significant oncology clinical development experience, including regulatory submissions and statistical strategy leadership.
Knowledge of real-world data sources, integration, and interpretation.
Recognised scientific contributions (publications, presentations, or working groups such as ASCO/ESMO).
Strong leadership presence in external regulatory/HTA/scientific discussions.
Proficiency in SAS (R preferred), with solid understanding of data management and programming practices.