Programming Contractor
ProKidney(4 months ago)
About this role
This role is a senior statistical programming position supporting clinical trials, focused on producing regulatory-compliant analysis datasets and outputs for submissions. The programmer works within cross-functional project teams to ensure inspection-ready documentation, adherence to SOPs and regulatory guidelines, and effective communication of programming progress and issues.
Required Skills
- SAS
- SDTM
- ADaM
- Data Mapping
- Validation Programming
- Quality Control
- Documentation
- CRF Annotation
- Regulatory Compliance
- Statistical Programming
+1 more
Qualifications
- 10+ Years Experience in Pharma/Biotech/CRO
- Master's Degree in Statistics, Computer Science, or Related (Preferred)
- Phase 3 and BLA/NDA Submission Experience (Preferred)
About ProKidney
prokidney.comProKidney is a late clinical‑stage biotechnology company developing a first‑in‑class cell therapy candidate to treat advanced chronic kidney disease (CKD). Their lead program aims to preserve kidney function in patients who have limited therapeutic options and to transform the therapeutic landscape for progressive CKD. As a pioneer in CKD therapeutics, ProKidney is advancing clinical development to demonstrate safety and efficacy of regenerative approaches. The company focuses on addressing a major unmet need in kidney disease through novel cell‑based treatments.
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