ProKidney offers treatment of chronic kidney disease (CKD) through innovations in cellular therapy. Backed by North Carolina Biotechnology Center.
About the role
The Statistical Programmer Contractor is responsible for developing, validating, and maintaining SAS programming deliverables to support clinical study analysis and reporting. This role collaborates closely with Biostatistics and other cross-functional team members to produce high-quality, compliant datasets, tables, listings, and figures while ensuring adherence to project timelines, SOPs, regulatory requirements, and CDISC standards.
What they're looking for
- Bachelor’s degree required, Master’s degree preferred in Statistics, Biostatistics, Mathematics, Computer Science, or a related field
- Minimum of 10 years of relevant statistical programming experience within the pharmaceutical, biotechnology, or CRO industry
- Phase 3 and regulatory submission experience preferred
- Strong SAS programming skills, with experience developing SDTM, ADaM, tables, listings, and figures
- Strong knowledge of clinical trial processes, regulatory requirements, and programming documentation
- High attention to detail, with strong analytical, problem-solving, and communication skills
More about this role
The Statistical Programmer Contractor is responsible for developing, validating, and maintaining SAS programming deliverables to support clinical study analysis and reporting. This role collaborates closely with Biostatistics and other cross-functional team members to produce high-quality, compliant datasets, tables, listings, and figures while ensuring adherence to project timelines, SOPs, regulatory requirements, and CDISC standards.
- Program and validate tables, listings, figures, and derived datasets using SAS.
- Develop SDTM and ADaM specs, datasets, and supporting documentation.
- Prepare and review mapping specifications, annotated case report forms (aCRF), define, SDRG, ADRG and other files needed in the submission.
- Perform quality control and validation activities for all programming deliverables.
- Collaborate with study team members to identify, investigate, and resolve data and output issues.
- Review study documents and provide input to improve programming quality, efficiency, and consistency.
- Maintain complete, accurate, and audit-/inspection-ready programming documentation.
- Communicate project status, risks, issues, and timeline impacts clearly to...
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