Senior Director, Biostatistics, Europe
This a Full Remote job, the offer is available from: Europe
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
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.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact [email protected]. #DNI
We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message.
Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.
If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to [email protected] so we can share these impersonations with our IT team for tracking and awareness.
This offer from "Revolution Medicines" has been enriched by Jobgether.com and got a 87% flex score.
Apply Now
Apply Now
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
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.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact [email protected]. #DNI
We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message.
Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.
If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to [email protected] so we can share these impersonations with our IT team for tracking and awareness.
This offer from "Revolution Medicines" has been enriched by Jobgether.com and got a 87% flex score.
Apply Now
Apply Now