Phase 3 Biostatistics Lead - Senior Director

Prokidney; Winston-Salem (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

ProKidney is seeking a Senior Director of Biostatistics to serve as the statistical lead for its pivotal Phase 3 program. This hands-on role combines strategic oversight with direct involvement in study design, analysis, and regulatory deliverables.

You will drive statistical strategy, oversee external vendors, interact with FDA, and partner with clinical development, data management, data science, pharmacovigilance and leadership to ensure rigorous, timely readouts.

Qualifications

• Advanced degree in statistics/biostatistics or related field
• 10+ years of pharmaceutical/biopharma experience with late-stage programs
• Proficiency in SAS, R, Python and related tools

Responsibilities

• Lead statistical strategy for Phase 3 program and regulatory deliverables
• Oversee study design, SAPs, analyses, tables, listings and figures
• Collaborate across clinical development, regulatory, data management and leadership

Job description

ProKidney is seeking a Senior Director of Biostatistics to serve as the statistical lead for its pivotal Phase 3 program. This hands-on role combines strategic oversight with direct involvement in study design, analysis, and regulatory deliverables.

You will drive statistical strategy, oversee external vendors, interact with FDA, and partner with clinical development, data management, data science, pharmacovigilance and leadership to ensure rigorous, timely readouts.