Associate Director, Biostatistics Clinical Late Stage

Responsibilities

• Serve as a study level statistician for oncology studies in clinical late-stage development
• Represent biostatistics on study and cross-functional project teams
• Lead and manage biostatistical activities to ensure scientific rigor and timely deliverables
• Provide statistical expertise for design, analysis, and reporting of clinical studies
• Develop statistical analysis plans and analysis specifications
• Collaborate with statistical programming, data management, and clinical operations
• Provide statistical input for global health authority documents and regulatory interactions
• Contribute to the development of functional-level standards, SOPs, and templates

Requirements

• Ph.D. in Statistics/Biostatistics with 5+ years of biotech/pharma experience, or M.S. with 8+ years
• Hands-on experience in design and analysis of late-stage oncology trials
• Solid knowledge of ICH and regulatory requirements for clinical trials
• Proficiency in SAS and/or R
• Strong verbal and written communication skills
• Excellent interpersonal and project management skills

Preferred Qualifications

• Hands-on experience in design and analysis of phase 3 oncology trials

About the Company

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers.