Director, Biostatistics, Late Clinical Stage

About the role

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. As a lead statistician for clinical program(s) and studies in clinical late-stage development, you will serve as 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, proof of concept criteria, and team’s preparation for company governance reviews.
• Represent the Biostatistics function on cross-functional teams 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.
• Plan and prepare independent data monitoring committee (DMC) activities, coordinate with independent statistical data analysis centers for DMC, and support periodic 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 are developed for datasets and outputs generation, ensuring statistical analyses specified in protocols and/or analysis plans are conducted appropriately.
• Provide statistical input and leadership for 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 functional and cross-functional team members.

Requirements

• Ph.D. or M.S. in Statistics/Biostatistics.
• Minimum of 8 years (for Ph.D.) or 12 years (for M.S.) of experience in the biotech/pharma industry as a statistician.
• Hands-on experience in design and analysis of late-stage oncology trials.
• 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.
• Good interpersonal and project management skills.
• Proficiency in SAS and/or R.

Preferred Skills

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

Pay

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is $211,000 - $264,000 USD. The range displayed is intended for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Base pay salary is determined by role, level, location, job-related skills, experience, and market dynamics.