Job Details

Overview

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

We are seeking an experienced and dynamic Executive Director of Biostatistics to lead our oncology programs. This pivotal role involves providing strategic and technical leadership in the design and execution of statistical strategies, study designs, analyses, and regulatory submissions for late-phase oncology clinical trials. The successful candidate will be instrumental in building and enabling a high-performing biostatistics team dedicated to advancing our oncology pipeline. This role will report directly to the Vice President, Biostatistics.

• Lead a biostatistics team for late-phase oncology programs, ensuring alignment with clinical development goals and regulatory requirements.
• Lead biostatistical strategy development for pivotal phase II/III trials, including adaptive designs and registration enabling trials.
• Partner closely with other subfunctions within quantitative sciences and with cross-functional teams, including clinical development, statistical programming, and regulatory affairs, to integrate statistical considerations into clinical development plans.
• Build, lead, and mentor a high-performing team of biostatisticians specializing in late-phase oncology development.
• Lead biostatistical activities for regulatory submissions.
• Develop and implement policies, standards, and procedures to ensure consistency and quality in statistical practices.
• Manage relationships with external partners, such as contract research organizations (CROs), ensuring adherence to timelines, budgets, and quality standards.

Required Skills, Experience and Education

• D. or M.S. in Statistics/Biostatistics, a minimum of 15 years (for Ph.D.) and 17 years (for M.S.) of experience in biotech/pharma industry as a statistician, with at least 8 years in a leadership role within late-phase oncology Biostatistics.
• Successful direct experience with FDA, EMA and PMDA interactions including regulatory meetings and response to agency questions.
• Proven track record with successful regulatory submissions (NDA/MAA/J-DNA) to FDA, EMA, and PMDA.
• Proven ability to influence cross-functional teams, drive strategic initiatives, and mentor statistical talent.
• Solid knowledge in ICH and other regulatory requirements related to biostatistical activities and clinical trials.
• Strong communication skills with ability to present complex statistical concepts to diverse audiences.
• Excellent interpersonal and project management skills are essential.
• Proficiency in SAS and/or R.