Statistical Programming Contractor

ProKidney Corp.; Northern (KY); Hybrid; USD 120,000 - 160,000; Full time

Job summary

ProKidney Corp. is seeking a Statistical Programmer Contractor to develop, validate, and maintain SAS programming deliverables supporting clinical study analysis and reporting.

You will collaborate with Biostatistics and cross‑functional teams to produce SDTM and ADaM datasets, tables, listings, and figures while ensuring CDISC compliance, SOP adherence, and timely delivery.

Qualifications

• Bachelor’s degree required in a related field.
• Minimum 10 years of statistical programming experience in pharma/biotech/CRO.
• Experience with SDTM/ADaM and regulatory submissions is preferred.

Responsibilities

• 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 of 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 stakeholders.
• Other as assigned.

Skills

SAS programming

SDTM/ADaM development

Clinical trial data handling

Quality control and validation

Documentation

Education

Bachelor's degree in Statistics/Biostatistics/Computer Science or related field

Tools

SAS

Job description

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.

Responsibilities:

• 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 stakeholders.
• Other as assigned.

Qualifications:

• 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.
• Ability to work independently and manage multiple priorities in a deadline-driven environment.

ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.