Associate Director, Biostatistics - Late Stage

Revolution Medicines•Redwood City, CA

2d•$186,000 - $233,000•Hybrid

About The Position

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: This position serves as a study level statistician for oncology studies in clinical late-stage development and provides leadership across biostatistical activities. The Associate Director will collaborate across functions and contribute to program-level decision-making. Represent biostatistics on study and cross-functional project teams, providing statistical leadership. Lead and manage biostatistical activities to ensure consistency, scientific rigor, and timely deliverables. Provide statistical expertise for design, analysis and reporting of clinical studies. Develop statistical analysis plans and analysis specifications; ensure analyses align with clinical and regulatory objectives. Collaborate with statistical programming to ensure that analysis is conducted per statistical plan and specifications and delivered with high quality. Collaborate with data management and clinical operations to ensure robust CRF and database development and quality data collection. Provide statistical input to the development of global health authority documents, regulatory interaction, and response to health authority submissions. Influence strategy and inform decision-making through data-driven insights and clear communication of risk and benefit. Collaborate in publications, assist in data interpretation, and ensure consistency and accuracy in data presentation. Contribute to the development of functional-level standards, SOPs, and templates. Keep abreast in 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, a minimum of 5 years (for Ph.D.) and 8 years (for M.S.) of experience in 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.

Nice To Haves

Hands-on experience in design and analysis of phase 3 oncology trials is desirable.

Responsibilities

Represent biostatistics on study and cross-functional project teams, providing statistical leadership.
Lead and manage biostatistical activities to ensure consistency, scientific rigor, and timely deliverables.
Provide statistical expertise for design, analysis and reporting of clinical studies.
Develop statistical analysis plans and analysis specifications; ensure analyses align with clinical and regulatory objectives.
Collaborate with statistical programming to ensure that analysis is conducted per statistical plan and specifications and delivered with high quality.
Collaborate with data management and clinical operations to ensure robust CRF and database development and quality data collection.
Provide statistical input to the development of global health authority documents, regulatory interaction, and response to health authority submissions.
Influence strategy and inform decision-making through data-driven insights and clear communication of risk and benefit.
Collaborate in publications, assist in data interpretation, and ensure consistency and accuracy in data presentation.
Contribute to the development of functional-level standards, SOPs, and templates.
Keep abreast in new developments in statistics, drug development, and regulatory guidance and share knowledge with functional and cross-functional team members.