Associate Director/Director, Regulatory Project Management
BridgeBio
Spring
Director/Senior Director, Biostatistics
PATHOS
full-time
Posted on:
Origin: • 🇺🇸 United States • New York
Visit company websiteJob Level
Senior
About the role
- Lead statistical design and analysis for oncology clinical studies (Phases I–III)
- Develop and review statistical sections of protocols, SAPs, study reports, and regulatory documents
- Execute and oversee interim and final analyses, ensuring high scientific rigor
- Apply advanced statistical methodologies (e.g., survival analysis, Bayesian, adaptive designs)
- Collaborate with data management and programming teams to ensure data quality and analysis readiness
- Support preparation of regulatory submissions and agency interactions (FDA, EMA, etc.)
- Serve as the statistical expert on cross-functional study teams
- Contribute to developing tools, templates, and best practices for the growing biostatistics function
- Report to the Vice President, Head of Clinical Development
Requirements
- PhD or MS in Biostatistics (or related field)
- 7–12 years of industry experience in biostatistics (oncology preferred)
- Hands-on expertise in clinical trial design, statistical analysis, and regulatory deliverables
- Strong SAS/R programming skills
- Demonstrated success with innovative trial methodologies (e.g., adaptive, Bayesian)
- Excellent communicator and collaborator across clinical, regulatory, and data teams
- Thrives in a dynamic, fast-paced environment
