Director, Biostatistics - Early Phase

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 RAS(ON) Inhibitors and RAS Companion Inhibitors support targeted treatment strategies. As a new member of the Revolution Medicines team, you will join a team dedicated 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 and the subject matter expert (SME) in Biostatistics within the Quantitative Sciences function, this position provides statistical leadership and support for clinical development strategy and clinical studies through the product life cycle.

Responsibilities

• Provide statistical support and strategic input to clinical development plans and target product profiles, proof of concept criteria, and the team’s preparation for company governance reviews.

• Represent Biostatistics on cross-function teams at the program level and serve as a lead statistician for oncology studies.

• Collaborate with various functions on study design, planning, protocol development, statistical analysis plan and analysis specifications.

• Provide statistical support for study protocol development, analysis plan and specifications through direct involvement and/or guidance to junior staff.

• Plan and prepare independent data monitoring committee (DMC) activities, coordinate with an independent statistical data analysis center for DMC reviews.

• Collaborate with data management and clinical operations to provide statistical input to study conduct, database development, data collection and cleaning activities.

• Collaborate with statistical programming to ensure appropriate programs and documentation for datasets development and outputs generation, and ensure analyses align with protocols and analysis plans.

• Provide statistical input and leadership to the development of global health authority documents, regulatory interactions and responses to health authority submissions.

• Provide statistical support for clinical publications and 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 team members.

Qualifications

• 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 required.

• Ability to work independently and within a team.

• Solid knowledge of ICH and other regulatory requirements related to biostatistical activities and clinical trials.

• Excellent verbal and written communication skills.

• Strong interpersonal and project management skills.

• Proficiency in SAS and/or R.

Preferred Skills

• Active participation in NDA/BLA filing through label negotiations desirable.

Note: This description reflects the current responsibilities and qualifications for the role and is not a contract. Revolution Medicines is an equal opportunity employer.

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