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 datasets and supporting documentation.
- Prepare and review mapping specifications and annotated case report forms (CRFs).
- Perform quality control and validation activities for 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.
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.