ppbSenior Director, Global Biometrics Analytics | Global Pharmaceutical Company | Hybrid | Italy / Sweden | Permanent /b /ppA leading global pharmaceutical organisation is looking to appoint an accomplished bSenior Director of Global Biostatistics /b to join its RD leadership team during an exciting period of scientific growth and transformation. The opportunity is also open to other areas including; France, UK. /ppReporting directly to the bHead of Global Clinical Development /b, you will lead the strategic direction of the global Biostatistics function, influencing clinical development programmes from early proof-of-concept through to regulatory approval. /ppThis role is ideally suited to a senior statistician who enjoys remaining scientifically hands‑on while shaping development strategy across a global portfolio. Working closely with executive stakeholders, you will drive statistical innovation, champion modern methodologies, and help accelerate drug development through robust, data‑driven decision making. /ppYou will also provide leadership to an established global Biometrics organisation of around b30 professionals /b spanning bBiostatistics, Statistical Programming and Data Management /b. Although you will have overall functional responsibility, the emphasis of this position is on scientific leadership, strategic direction and technical excellence rather than day‑to‑day operational management. /ph3Key Responsibilities /h3ulliProvide strategic statistical leadership across global early and late-phase clinical development programmes. /liliDevelop and execute the overarching Biostatistics strategy in alignment with Clinical Development and wider RD objectives. /liliLead statistical contributions to clinical development plans, study designs, protocol development and regulatory submission strategies. /liliDrive the adoption of innovative statistical methodologies, including Bayesian approaches, adaptive trial designs,



interim analyses and model-informed drug development. /liliAdvise on complex statistical challenges such as sparse data analysis, evidence synthesis and hypothesis generation. /liliFamiliarity with Bayesian statistics /liliOversee the development and review of Statistical Analysis Plans (SAPs), interpretation of clinical trial results and statistical content for regulatory submissions. /liliPartner with Clinical Development, Regulatory Affairs, Medical Affairs and Clinical Operations to influence programme strategy and key development decisions. /liliMentor and develop a high-performing global statistical organisation while promoting a collaborative, innovative and scientifically rigorous culture. /liliRepresent the Biostatistics function within governance forums and during interactions with health authorities and external scientific collaborators. /li /ulh3Candidate Profile /h3pTo be successful, you will have: /pulliAn MSc or PhD in Biostatistics, Statistics, Mathematics or another quantitative discipline (PhD preferred). /liliSignificant leadership experience within Biostatistics in the pharmaceutical or biotechnology sector. (Direct reports) /liliStrong expertise supporting both early and late-stage clinical development programmes. /liliIn-depth knowledge of innovative statistical methods, including Bayesian statistics, adaptive designs and interim analyses. /liliExperience supporting accelerated regulatory pathways, proof-of-concept studies and contemporary drug development strategies. /liliA thorough understanding of GCP, ICH guidelines, CDISC standards (SDTM/ADaM) and global regulatory expectations.



/liliProgramming proficiency in SAS and/or R. /liliA proven track record of influencing senior stakeholders through scientific expertise and strategic thinking. /liliExperience leading and developing high-performing global teams. /liliPrevious experience within an agile biotech or innovation-focused pharmaceutical company would be advantageous. /liliKnowledge of Paediatric Investigation Plans (PIPs) or neonatal clinical development would be beneficial. /li /ulh3What's on Offer? /h3ulliHighly competitive salary, annual premio and comprehensive benefits package (country dependent). /liliHybrid working model with approximately one week per month on-site. /liliThe opportunity to shape the statistical direction of innovative global clinical development programmes. /liliExposure to cutting-edge approaches including Bayesian methodologies, adaptive trial designs, model-informed drug development and accelerated regulatory pathways. /liliThe chance to join a highly respected Biometrics leadership team with an outstanding collaborative culture and excellent staff retention. /liliWork within a people-first, sustainability-focused global pharmaceutical organisation recognised for investing in both scientific innovation and employee development. /liliExcellent long-term career progression within a growing global business. /li /ulh3Interested? /h3pIf you're an experienced Biostatistics leader looking to influence global drug development strategy while remaining scientifically engaged, we'd love to hear from you. Apply today with your CV, as our client is keen to appoint their new bSenior Director, Global Biostatistics /b as soon as possible. /ph3Looking for something different? /h3pFor a confidential discussion about this opportunity or other senior Biostatistics and Biometrics positions across the UK and Europe, please contact bAimee Weston /b at . /p /p #J-18808-Ljbffr

📌 Senior Director of Biometrics (Bologna)
🏢 Warman O'Brien
📍 Bologna