Principal CMC Statistician

We are a game-changing biotech start-up with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. We are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting edge drug development.

Requirements

• Proven statistical expertise across Analytical Development and Quality, driving critical CMC decision-making
• Statistical strategies for establishing process and product specifications
• Statistically supported PPQ strategies to validate processes and platforms
• Statistically robust study design and analysis to optimize manufacturing processes
• Build and maintain reproducible data science communication products
• Bridge scientific questions and computational solutions
• Collaborate closely with scientists and engineers on research themes
• Collaborate closely with Research and Clinical data scientists to form harmonized approaches and data management strategies
• Adherence to GMP when demanded by the specifics of projects

Benefits

• Medical, Dental, and Vision plans
• 401k plan with 100% match up to first 4% deferral
• Paid Time Off policy
• Employee commuter benefits
• Cell phone stipend