Develops, validates, and maintains SAS deliverables for clinical study analysis and regulatory reporting. Creates SDTM and ADaM datasets, specifications, tables, listings, figures, and submission documentation. Performs quality control, resolves data issues, ensures CDISC and regulatory compliance, maintains audit-ready records, and communicates project status, risks, and timelines to cross-functional stakeholders.
Position Summary:
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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Develops, validates, and maintains SAS programming deliverables for clinical study analysis and regulatory reporting. Creates SDTM and ADaM datasets, tables, listings, figures, specifications, and submission documentation. Performs quality control, resolves data and output issues, maintains audit-ready records, and collaborates with Biostatistics and cross-functional study teams while managing timelines, risks, and compliance with SOPs, regulations, and CDISC standards.
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