About the job
ProKidney is hiring a Statistical Programmer Contractor to support clinical study analysis and reporting. This remote contract position centers on developing, validating, and maintaining SAS programming deliverables. The contractor will work with Biostatistics and cross-functional teams to produce compliant datasets, tables, listings, and figures. Meeting project timelines, following SOPs, and adhering to regulatory guidelines and CDISC standards are key expectations.
Main responsibilities
- Program and validate tables, listings, figures, and derived datasets using SAS.
- Create SDTM and ADaM datasets along with supporting documentation.
- Prepare and review mapping specifications and annotated case report forms (CRFs).
- Perform quality control and validation for all programming deliverables.
- Work with study team members to identify and resolve data or output discrepancies.
- Review study documentation and provide feedback to improve programming quality and consistency.
- Maintain thorough, accurate, and audit-ready programming documentation.
- Communicate project status, risks, issues, and timeline impacts to stakeholders.
Requirements
- Bachelor’s degree required; Master’s in Statistics, Biostatistics, Mathematics, Computer Science, or a related field preferred.
- At least 10 years of statistical programming experience in pharmaceutical, biotechnology, or CRO settings.
- Experience with Phase 3 studies and regulatory submissions is highly valued.
- Advanced SAS programming skills, with experience in SDTM, ADaM, and generating tables, listings, and figures.
- Strong understanding of clinical trial processes, regulatory requirements, and programming documentation standards.
- Attention to detail, analytical thinking, and effective communication skills.
