Director, Biostatistics - Late Phase at Revolution Medicines

You're a seasoned Biostatistician with a Ph.D. or M.S. and at least 8 or 12 years of relevant industry experience, respectively, ready to lead statistical strat

Work type: hybrid

Location: Redwood City, California, United States

Salary: $211,000 – $264,000/yr

Type: Full-time

Summary

You're a seasoned Biostatistician with a Ph.D. or M.S. and at least 8 or 12 years of relevant industry experience, respectively, ready to lead statistical strategy for late-stage oncology clinical trials. **What makes it worth a look...** Revolution Medicines is offering a full-time, hybrid role in Redwood City, California, with a base salary range of $211,000 to $264,000 annually, plus competitive equity and benefits. **You might be a good fit if you...** * Have hands-on experience in designing and analyzing late-stage oncology trials. * Are proficient in SAS and/or R. * Possess solid knowledge of ICH and other regulatory requirements for clinical trials. * Can provide statistical input for global health authority documents and regulatory submissions.

Job Description

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), 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 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:

Playing a critical role as a lead statistician for clinical program(s) and studies in clinical late-stage development and the subject matter expert (SME) in Biostatistics within Quantitative Sciences function, this position is to provide statistical leadership and support for clinical development strategy and clinical studies through product life cycle.

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

• Represent Biostatistics function on cross-function 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), coordinate with independent statistical data analysis center for DMC and study team for periodic DMC reviews.

• 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 generation, and ensure 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 in new developments in statistics, drug development, and regulatory guidance and share knowledge with functional and cross-functional team members.

• 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 late-stage oncology trials is a must.

• Ability to work independently and within a team.

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

• Excellent verbal and written communication skills are required.

• Good interpersonal and project management skills are essential.

• Proficiency in SAS and/or R.

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

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

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