Programming Contractor

Prokidney; Winston-Salem (NC); On-site; USD 96,000 - 165,000; Full time

Job summary

ProKidney seeks a Statistical Programmer Contractor to develop, validate, and maintain SAS deliverables supporting clinical study analysis and reporting. You will produce high-quality, compliant datasets, tables, listings, and figures while meeting project timelines and regulatory standards.

You will collaborate with Biostatistics and cross-functional teams, document programming activities, and ensure audit-ready documentation for submissions.

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.

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 CRFs, define, SDRG, ADRG and other files needed for submission.
• Perform quality control and validation activities for all programming deliverables.
• Collaborate with study team to identify, investigate, and resolve data and output issues.
• Review study documents and provide input to improve programming quality, efficiency, and consistency.

Skills

Statistical programming

Clinical trial data analysis

QC/validation

Documentation

Education

Bachelor’s degree in Statistics/Biostatistics/Math/CS

Master’s degree preferred in Statistics/Biostatistics/Math/CS

Tools

SAS

SDTM

ADaM

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.

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