Senior Principal Statistician

Job Summary

Leading statistical efforts for clinical studies, the full-time Senior Principal Statistician will design and report on Phase I to IV clinical studies and regulatory filings, providing expertise in statistical strategy and analysis while collaborating with cross-functional teams in a remote environment.

Key responsibilities

• Participate in meetings to optimize clinical study designs and analysis strategies
• Develop and implement study protocols, including statistical analysis plans and data validation
• Act as a statistical subject matter expert, preparing for regulatory agency meetings and ensuring quality deliverables from CROs

Required qualifications

• MS or MPH in statistics, mathematics, or a related discipline with over 4 years of experience in the pharmaceutical or biotechnology industry, or PhD with over 2 years of experience
• Proficient in SAS and R programming, with knowledge of CDISC standards
• Experience with clinical trial design and analysis, including complex statistical methods
• Familiarity with regulatory requirements and guidelines related to statistical analysis
• Knowledge of oncology or hematology therapeutic areas is preferred