Statistical Programming Contractor

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.