About the Opportunity
Our client is seeking a contract Senior Statistical Programmer to independently lead programming activities for assigned clinical studies while maintaining hands-on involvement in programming, validation, and technical oversight. This remote role combines study-level ownership, strong knowledge of clinical study data, direct programming expertise, and oversight of internal and vendor-produced datasets, tables, listings, figures, and regulatory submission deliverables.
The base pay for this position is $70 to $85 per hour. Actual compensation offered to the successful candidate may vary from posted hiring range based upon geographic location, work experience, education, and/or skill level, among other things. Details about eligibility for bonus compensation (if applicable) will be finalized at the time of offer.
Job Responsibilities
- Lead study-level statistical programming activities, including planning, prioritization, timeline management, risk identification, and status reporting.
- Develop, program, and validate SDTM and ADaM datasets, tables, listings, and figures using SAS
- Collaborate closely with Biostatistics, Data Management, Clinical Operations, and other cross-functional teams to clarify requirements and resolve data, programming, and specification issues
- Review internally and externally developed programs, datasets, outputs, and regulatory submission deliverables to ensure accuracy, traceability, consistency, and compliance with CDISC standards and regulatory expectations
- Provide oversight and technical review of vendor deliverables, including specifications, datasets, tables, listings, figures (TFLs), define.xml, annotated CRFs, reviewer guides, transport files, and validation documentation
- Support clinical study publications, regulatory submissions, health authority requests, and inspection-readiness activities
- Monitor programming deliverables, dependencies, timelines, and risks, escalating significant issues and developing solutions as needed
- Partner with cross-functional stakeholders and external vendors to ensure programming activities remain aligned with study requirements and project timelines
Job Requirements
- Bachelor’s degree in Statistics, Biostatistics, Computer Science, Mathematics, Life Sciences, or a related quantitative discipline
- Minimum of 8+ years statistical programming experience in Biotech, Pharma, or CRO industry
- Strong knowledge of CDISC standards, including SDTM and ADaM
- Experience overseeing vendor deliverables and supporting regulatory submissions
