Senior Director, Biostatistics – Late Phase

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), elironrasib (RMC‑6291), zoldonrasib (RMC‑9805) and RMC‑5127 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

• Lead strategic, statistical thinking and contributions to clinical development plans.
• Represent Biostatistics function on cross‑function teams at program level and serve as a lead statistician for oncology studies.
• Collaborate with various functions on study design and planning, protocol development, statistical analysis plan and analysis specifications.
• Provide statistical support for study protocol development, analysis plan and specification through direct involvement and/or guidance to junior staff.
• Plan and prepare independent data monitoring committee (DMC), coordinate with an independent statistical data analysis center for DMC and study team for periodic DMC reviews.
• Collaborate with data management and clinical operations to provide statistical input to study conducts, database development, data collection and cleaning activities.
• Collaborate with statistical programming to ensure that appropriate programs and documentation are developed for datasets and outputs generation, and that the statistical analyses specified in scientific protocols and/or analysis plans are conducted appropriately.
• Provide statistical input and leadership to the development of global health authority documents, regulatory interaction and response to health authority submissions.
• Provide 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 of new developments in statistics, drug development, and regulatory guidance and share knowledge with functional and cross‑functional team members.

Required Skills, Experience and Education

• Ph.D. or M.S. in Statistics/Biostatistics, minimum 10 years (for Ph.D.) and 14 years (for M.S.) of experience in the biotech/pharma industry as a statistician. Level will be determined based on the relevance of experience.
• Extensive experience in design and conduct of phase 3 oncology trials.
• Solid knowledge in ICH and other regulatory requirements related to biostatistical activities and clinical trials.
• Excellent verbal and written communication skills.
• Good interpersonal and project management skills.
• Proficiency in SAS and/or R.

Preferred Skills

• Experience with lead role in NDA/BLA filing desirable.

Base Pay Salary Range

$244,000 - $305,000 USD

Equal Employment Opportunity

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.

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