Director, Biostatistics, Japan

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals 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 studies in Japan and the subject matter expert (SME) in Biostatistics within Quantitative Sciences function, this position is to provide statistical leadership and support for clinical development strategy and clinical studies in Japan through product life cycle. Provide statistical support and strategic input to clinical development plans and target product profiles, proof of concept criteria, and team’s preparation for company governance reviews. Represent Biostatistics function on cross-function teams and serve as a lead statistician for oncology studies in Japan. Lead statistical design and planning including protocol development, statistical analysis plan and analysis specifications. Provide statistical support for study protocol development, analysis plan and specification through direct involvement and/or providing guidance to junior staff. Plan and prepare independent data monitoring committee (DMC), coordinate with independent statistical data analysis center for DMC and study team for periodic DMC reviews for Japan related studies. Collaborate with data management and clinical operations over the course of clinical studies to provide statistical input to study conducts and database development as well as data collection and cleaning activities. 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. Lead statistical input and leadership to the development of health authority documents, regulatory interaction and response to health authority submissions. Guide statistical support for clinical publications, assist in data interpretation to ensure consistency and accuracy in data presentation. Drive and lead department initiatives, best practices, and guidelines. Keep abreast in new developments in statistics, drug development, and regulatory guidance in Japan and share knowledge with functional and cross-functional team members. Required Skills, Experience and Education: Ph.D. or M.S. in Statistics/Biostatistics, a minimum of 8 years (for Ph.D.) and 12 years (for M.S.) of experience in the biotech/pharma industry as a statistician. Level will be determined based on the relevance of experience. Hands-on experience in design and analysis of oncology trials is a must. 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 both in English and Japanese are required. Good interpersonal and project management skills are essential. Proficiency in SAS and/or R. Preferred Skills: Active participation in PMDA filing through label negotiations desirable. 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]. 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.