Senior Director, Biostatistics — Phase 3 Lead (FDA‑facing)

Prokidney; United States; Remote; USD 230,000 - 320,000; Full time

Job summary

ProKidney is seeking a Senior Director of Biostatistics to lead the statistical strategy for its pivotal Phase 3 program. This hands-on yet strategic role requires a technically strong statistician who can guide study design, analysis, and regulatory deliverables.

The ideal candidate will have FDA-facing experience, a deep background in biostatistics, and demonstrated ability to collaborate across clinical development, regulatory, data management, and leadership teams in a fast-paced environment.

Qualifications

• Advanced degree in Statistics/Biostatistics; PhD preferred.
• 10+ years pharma/biopharma experience in design and analysis of clinical studies.
• FDA-facing experience and capability to liaise with regulatory teams.
• Strong communication and cross-functional collaboration across development, regulatory, data, and leadership.

Responsibilities

• Lead statistical strategy for Phase 3 studies and regulatory deliverables.
• Oversee study design, SAPs, analyses, and interpretation of results.
• Manage external vendors and biostatistics SOPs to ensure quality.

Skills

Statistical analysis

Clinical trial design

Regulatory writing support

Education

PhD in Statistics/Biostatistics

Advanced degree in Statistics/Biostatistics

Tools

SAS

R

Python

Job description

ProKidney is seeking a Senior Director of Biostatistics to lead the statistical strategy for its pivotal Phase 3 program. This hands-on yet strategic role requires a technically strong statistician who can guide study design, analysis, and regulatory deliverables.

The ideal candidate will have FDA-facing experience, a deep background in biostatistics, and demonstrated ability to collaborate across clinical development, regulatory, data management, and leadership teams in a fast-paced environment.