ProKidney offers treatment of chronic kidney disease (CKD) through innovations in cellular therapy. Backed by North Carolina Biotechnology Center.
About the role
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.
What they're looking for
- Education/Training:
- Advanced degree in Statistics, Biostatistics, Mathematics, or related Ph.D. preferred
- Minimum of 10 years of pharmaceutical and/or biopharma industry experience, including design and analysis of clinical studies (cell therapies/biologics a plus)
- Formal education in statistics, biostatistics or the mathematical sciences
- Experience leading and reading out late stage programs
- Broad clinical trial expertise
More about this role
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.
- 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...
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