Associate Director, Biostatistics, Clinical Late Stage
Revolution Medicines
Summary
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.
Job description
- 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
- Minimum of 5 years (for Ph.D.) and 8 years (for M.S.) of experience in 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 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
- Hands-on experience in design and analysis of phase 3 oncology trials is desirable
Benefits
- Competitive cash compensation
- Equity awards
- Learning and development opportunities
Company overview
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers. The company is pioneering a new class of therapeutics that target oncogenic RAS mutations, which are among the most common drivers of human cancers. Revolution Medicines employs a unique approach to drug discovery, leveraging deep insights into RAS biology to develop small molecule inhibitors that can address previously undruggable targets. Their pipeline includes multiple clinical-stage candidates designed to inhibit various RAS pathway mutations, with a particular focus on KRAS G12C and other RAS variants. The company's scientific platform combines structural biology, medicinal chemistry, and computational approaches to design highly selective inhibitors. Revolution Medicines aims to transform cancer treatment by developing therapies that can overcome resistance mechanisms and provide durable clinical benefits for patients with RAS-driven malignancies. Their research represents a significant advancement in the field of targeted cancer therapy, addressing one of the most challenging areas in oncology drug development.