Senior Director, Biostatistics, Europe

The Opportunity

Playing a critical role as a lead statistician for clinical program(s) and the subject matter expert (SME) in Biostatistics within the Quantitative Sciences function, this position is to provide statistical leadership and support for EU access strategies, healthcare technology assessments and regulatory submissions. 

• Serve as the statistical lead for European access strategies, ensuring alignment between Global Clinical Development, European regulatory (EMA, MHRA, Swissmedic...) and regional/local Market Access needs to support successful European launches in collaboration with global and regional crossfunctional teams.

• Partner with Regional and Local Market Access and HEOR functions to design and lead/oversee the execution of statistical analyses required for value dossiers, including PICO, indirect treatment comparisons, network meta-analyses, and RWE generation.

• Partner closely with the development statistical lead, provide statistical support for EU regulatory interactions, including EMA Scientific Advice, MAA, Type II variations, and post-authorization commitments.

• Ensure statistical methodologies align with EU guidance (ICH, EMA guidelines, CHMP expectations). 

• Contribute to the global statistical strategy, ensuring study designs and endpoints satisfy both regulatory approval and reimbursement dossier standards in Europe, proactively addressing diverse data requirements for payers across different European jurisdictions.

• Provide statistical expertise and support for regional study projects including study design, data analysis, and interpretation of results, to ensure high-quality and scientifically sound outcomes.

• Collaborate with statistical programming to ensure that appropriate programs and documentations are being developed for datasets development and outputs generation, and ensure the statistical analyses specified in scientific protocols and/or analysis plans are conducted appropriately.

• Drive and lead department initiatives, best practices, and guidelines.

Required Skills, Experience and Education

• Ph.D. or M.S. in Statistics/Biostatistics or related fields, a minimum of 10 years (for Ph.D.) and 15 years (for M.S.) of experience in the biotech/pharma industry as a statistician.

• Ability to work independently and within a team.

• Solid knowledge in ICH and other regulatory requirements related to biostatistical activities and clinical trials.

• Excellent verbal and written communication skills are required.

• Good interpersonal and project management skills are essential.

• Advanced methodological and technical skills.

• Strong problem solving and critical thinking abilities.

• Proficiency in SAS and/or R.

Preferred Skills:

• Strong track record in submitting with EMA filing with proven experience in supporting HTA submissions (e.g. to GBA, HAS) as well as reimbursement dossier contributions in major European markets.

• Experience in engaging with European scientific advice/early payer.

• Deep understanding of evolving landscape of EMA, MHRA and Swissmedic, and the evolving landscape of joint clinical assessments (JCA) in Europe, in addition to European legislation requirements.

• Active participation in NDA/BLA filing through label negotiations advantageous.

• Hands-on experience in design and analysis of oncology trials.

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