Jobs at ProKidney Corp.

Leads CMC planning and project management for late-stage and commercial cell therapy programs. Translates CMC strategy into cross-functional plans, milestones, deliverables, risk mitigations, and regulatory submission timelines through BLA filing, inspection, and approval. Coordinates Operations, Quality, Regulatory, and technical teams; manages dependencies, escalations, reporting, and change decisions. Establishes CMC planning standards and leads project managers while supporting technology transfer, comparability, scale-up, validation, and cGMP activities.

Develops, validates, and maintains SAS deliverables for clinical study analysis and regulatory reporting. Creates SDTM and ADaM datasets, specifications, tables, listings, figures, and submission documentation. Performs quality control, resolves data issues, ensures CDISC and regulatory compliance, maintains audit-ready records, and communicates project status, risks, and timelines to cross-functional stakeholders.

Develops, validates, and maintains SAS programming deliverables for clinical study analysis and regulatory reporting. Creates SDTM and ADaM datasets, tables, listings, figures, specifications, and submission documentation. Performs quality control, resolves data and output issues, maintains audit-ready records, and collaborates with Biostatistics and cross-functional study teams while managing timelines, risks, and compliance with SOPs, regulations, and CDISC standards.

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.