Job Description
About the Role
Lead statistical strategy for Phase III clinical trials of novel oncology therapies while ensuring regulatory compliance.
Responsibilities
- Design adaptive clinical trial protocols
- Develop SAP and statistical analysis plans
- Review CDISC compliant datasets
- Prepare DSMB reports
- Collaborate with FDA/EMA statisticians
- Implement Bayesian methods
- Mentor junior staff
Requirements
- PhD in Biostatistics
- 7+ years pharma experience
- Expertise in SAS/R/Python
- Experience with NDA submissions
- Knowledge of ICH guidelines
- Oncology therapeutic experience
- FDA interaction experience
Benefits
- Stock options
- Pharma discount program
- Post-doc sponsorship
- Onsite daycare
- Tuition reimbursement
About the Company
Pfizer discovers, develops, and manufactures healthcare products, including innovative medicines and vaccines for oncology, immunology, and rare diseases.
Job ID: principal-biostatistician-027
