Associate Director Biostatistics

Warman O'Brien

  • United Kingdom
  • Permanent
  • Full-time
  • 16 days ago
5901 Posted: 19/08/2025
  • £Competitive
  • Home Based , , United Kingdom
  • Permanent
Associate 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 an experienced Associate Director Biostatistics to join them.This is an organisation where excellence is not just expected, it's cultivated. Known for its open, forward-thinking culture and genuine commitment to purpose-driven science, the company provides an environment that inspires, supports, and rewards. Every contribution here matters. Every voice is valued. And every project pushes the boundaries of what's possible in modern medicine.As an Associate 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.What you will be doing:
  • Lead statistical strategy for haematology oncology, serving as compound-level statistical lead across development, evidence generation, and regulatory/payer interactions.
  • Develop integrated statistical strategies across trial phases (early, pivotal, RWE, post-marketing), aligned with product profile and development goals.
  • 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.
  • Present findings clearly to stakeholders and leadership.
  • Ensure integrated data availability for submissions and marketing support.
  • Contribute to due diligence, data review, and expert statistical guidance.
  • Implement and oversee advanced statistical methods.
What you will need:
  • PhD or Master's in Biostatistics, Statistics, or related field.
  • Significant oncology clinical development experience, including regulatory submissions and statistical strategy leadership.
  • Expertise across trial design, biomarkers, exploratory analytics, RWE, safety, and post-marketing support.
  • Experience with Bayesian methods, adaptive designs, external control arms, and AI/ML in clinical development.
  • 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.
  • Experience in international teams and ability to communicate complex methods clearly.
What to do next:
If this opportunity is of interest, please apply now with your CV to avoid disappointmentNot what you are looking for?Please contact Jo Fornaciari jo@warmobrien.com for a confidential discussion about other potential opportunities.

Warman O'Brien