Senior Director, Biostatistics

Responsibilities

• Serve as the statistical lead for the pivotal Phase 3 program
• Lead statistical strategy, analysis, interpretation, and reporting for complex clinical trial data
• Author statistical analysis plans, tables, listings, and figures shells
• Oversee external vendors and lead the biostatistical team
• Support FDA-facing discussions and advocate for analytical approaches
• Contribute to executive-level program updates and risk management
• Develop and maintain biostatistics SOPs

Requirements

• Advanced degree in Statistics, Biostatistics, Mathematics, or related field (Ph.D. preferred)
• Minimum of 10 years of pharmaceutical and/or biopharma industry experience
• Proven experience leading and reading out late stage programs
• Proficiency in SAS, R, Python, or related data analysis languages
• Prior involvement in BLA/NDA submission planning and execution
• Strong academic background in quantitative methods and predictive modeling

About the Company

ProKidney is a biopharmaceutical company focused on developing innovative therapies for kidney disease.