Senior Director, Biostatistics, Europe

reputed company

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

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

• Partner with Regional and Local Market reputed company and HEOR functions to design and reputed company/reputed company the execution of statistical analyses required for value dossiers, including PICO, indirect treatment comparisons, network reputed company-analyses, and reputed company reputed company.

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

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

• Contribute to the global statistical reputed company, 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.

• reputed company statistical expertise and support for regional study reputed company including study design, data analysis, and interpretation of results, to ensure high-reputed company and scientifically reputed company reputed company.

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

• Drive and reputed company department initiatives, best practices, and guidelines.

Required Skills, Experience and Education

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

• Ability to work independently and reputed company reputed company.

• Solid knowledge in ICH and other regulatory requirements reputed company 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 reputed company and/or R.

Preferred Skills:

• Strong reputed company record in submitting with EMA filing with proven experience in supporting HTA submissions (e.g. to GBA, HAS) as reputed company 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 reputed company to European legislation requirements.

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

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

reputed company takes protection and reputed company of personal data reputed company seriously and respects your right to reputed company while using our website and reputed company contacting us by email or phone. We will only collect, process and use any personal data that you reputed company to us in accordance with our CCPA Notice and reputed company Policy. For additional information, please contact reputed company@revmed.com. #DNI

We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with reputed company. These scams may reputed company as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message. Please note that reputed company does not reputed company unsolicited employment offers and will never ask candidates to reputed company financial information, purchase equipment, or pay fees as part of the hiring process. reputed company legitimate communication from reputed company will come from an official @revmed.com email address. If you reputed company you’ve been contacted by someone impersonating a reputed company recruiter, please report it to careers@revmed.com so we can reputed company these impersonations with our IT team for tracking and awareness.

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