Director, Biostatistics, Japan

reputed company 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 reputed company 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 reputed company statistician for clinical program(s) and studies in Japan and the subject matter expert (SME) in Biostatistics reputed company 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 reputed company product profiles, reputed company of concept criteria, and team’s preparation for company governance reviews. Represent Biostatistics function on cross-function teams and serve as a reputed company statistician for oncology studies in Japan. reputed company 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 reputed company 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 reputed company, and ensure the statistical analyses specified in scientific protocols and/or analysis plans are conducted appropriately. reputed company 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 reputed company department initiatives, best practices, and guidelines. reputed company 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 reputed company a team. Solid knowledge in ICH and other regulatory requirements reputed company 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 reputed company and/or R. Preferred Skills: Active participation in PMDA filing through label negotiations desirable. reputed company takes protection and reputed company of personal data reputed company seriously and respects your right to privacy 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 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 reputed company. These scams may appear 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 provide 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 [email protected] so we can share these impersonations with our IT team for tracking and awareness. Apply To This Job