Warman O'Brien
Senior Director, Global Biostatistics
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Senior Director, Global Biostatistics | Global Pharma| Hybrid | UK / France | Permanent
An exciting opportunity has arisen for an experienced Global Director, Biostatistics to join a global, innovation-led pharmaceutical company at a pivotal stage in its R&D transformation.
Reporting to the Head of Global Clinical Development, you will provide strategic and scientific leadership for the global Biostatistics function, playing a critical role in shaping clinical development programmes from early proof-of-concept through to registration.
This is an outstanding opportunity for an experienced statistician who wants to remain technically involved while influencing development strategy at the highest level. You will drive statistical excellence across multiple therapeutic areas, champion innovative methodologies and work alongside senior leaders to accelerate clinical development through modern trial designs and data-driven decision making.
Whilst leading an established team of approximately 30 professionals across Biostatistics, Statistical Programming and Data Management, this role is primarily focused on providing expert statistical leadership and strategic direction rather than purely operational management.
What you will be doing:
- Provide scientific leadership for Biostatistics across global early and late-phase clinical development programmes.
- Define and implement the global statistical strategy aligned with Clinical Development and R&D objectives.
- Lead statistical input into clinical development plans, study design, protocol development and regulatory submission strategies.
- Champion innovative statistical methodologies, including Bayesian approaches, adaptive trial designs, interim analyses and model-informed drug development.
- Provide expert guidance on complex statistical challenges, including sparse data, evidence integration and hypothesis generation.
- Oversee the development of Statistical Analysis Plans, interpretation of clinical data and statistical reporting for regulatory submissions.
- Collaborate closely with Clinical Development, Regulatory Affairs, Medical Affairs and Clinical Operations to influence programme strategy and key development decisions.
- Build and develop high-performing statistical teams while fostering a collaborative, innovative and scientifically driven culture.
- Represent Biostatistics within governance committees and during interactions with regulatory agencies and external scientific partners.
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What you will need:
- MSc or PhD in Biostatistics, Statistics, Mathematics or a related quantitative discipline (PhD preferred).
- Extensive experience leading Biostatistics within the pharmaceutical or biotechnology industry.
- Strong experience supporting both early and late-stage clinical development.
- Advanced expertise in innovative statistical methodologies, including Bayesian statistics, adaptive designs and interim analyses.
- Experience contributing to accelerated regulatory pathways, proof-of-concept studies and modern drug development strategies.
- Excellent understanding of GCP, ICH guidelines, CDISC standards (SDTM/ADaM) and global regulatory requirements.
- Strong programming knowledge using SAS and/or R.
- Demonstrated ability to influence senior stakeholders through technical expertise and strategic insight.
- Proven leadership experience developing high-performing teams within a global environment.
- Experience within an agile biotech or innovation-focused pharmaceutical organisation would be highly advantageous.
- Knowledge of Paediatric Investigation Plans or neonatal development programmes would be beneficial.
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What's in it for you:
- Competitive salary, annual bonus and comprehensive benefits package (country dependent).
- Hybrid working with approximately one week per month on-site.
- The opportunity to shape the statistical strategy behind innovative global clinical development programmes.
- Exposure to cutting-edge methodologies including Bayesian statistics, adaptive trial design, model-based R&D and accelerated regulatory pathways.
- Join a collaborative, highly respected biometrics leadership team with an excellent culture and strong employee retention.
- Work for a people-focused, sustainability-driven global pharmaceutical company recognised for investing in its employees and scientific innovation.
- Excellent long-term career development and progression opportunities.
What to do next:
If this opportunity is of interest, please apply now with your CV as the organisation is looking to welcome an experienced Global Director, Biostatistics to the team as soon as possible.
Not what you're looking for? Please contact Jo Fornaciari at jo@warmanobrien.com for a confidential discussion about potential other opportunities across the UK and Europe.
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