Biostatistics Director

Position Summary:

ProKidney is seeking a Senior Director, Biostatistics to serve as the statistical lead for its pivotal Phase 3 program. This highly visible, hands-on role requires a technically strong statistician who can operate strategically while remaining close to the work.

The Senior Director will lead statistical strategy, analysis, interpretation, and reporting for complex clinical trial data, while supporting regulatory interactions, topline readout, and future submission activities. The ideal candidate will bring deep statistical expertise, strong drug development judgment, FDA-facing experience, and the ability to collaborate effectively across clinical development, regulatory, data management, data science, pharmacovigilance, quality, and executive leadership.

Essential Duties & Responsibilities:

•  Phase 3 study lead; accountable for not only study read out but all biostatistics elements that will subsequently feed into a BLA, such as the integrated safety summary.
• Provide hands-on statistical leadership for study design, statistical analysis plans, data interpretation, reporting, and regulatory deliverables.
• Key member of the cross functional core study team who represents the interests of the biostatistics deliverables while overseeing the overall study conduct.
• Escalation point and oversight of all external vendors, such as WCG for the Endpoint Adjudication committee and Icon for Central Laboratory
• Functional lead of the biostatistical team
• Leader who maintains composure and creative problem solving in a flexible, fast paced
• Accountable author of the statistical analysis plan, tables listings and figures shells, and subsequent documentation
• Provide statistical leadership for complex issues including randomized versus treated populations
• Leads trial design, protocol development, analysis planning, interpretation of results and preparation of regulatory submissions
• Generates statistical models to improve methods of evaluating quantitative and qualitative data, identifying relationships and trends in data and factors affecting research results.
• Support FDA-facing discussions and help advocate for appropriate analytical approaches in a complex and differentiated therapeutic setting.
• Provides ad hoc data driven analyses
• Independently research, propose, teach and implement advanced statistical analyses
• Accountable and responsible for biostatistics SOP development and maintenance
• Contribute to executive-level program updates, including biweekly interactions with senior leadership regarding study progress, key risks, upcoming milestones, and decision points.