ProKidney Corp.
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Biotech
Lead biostatistical strategy and execution for a pivotal Phase 3 program, including study design, analysis plans, data interpretation, reporting, regulatory submissions, and FDA interactions. Oversee biostatistics vendors, develop SOPs, support BLA activities, conduct advanced analyses, and communicate study risks and milestones to executive leadership. Collaborate cross-functionally across clinical development, regulatory, data management, pharmacovigilance, quality, and data science teams.
