Statistical Programmer

The Senior Statistical Programmer will independently lead programming activities for assigned clinical studies while maintaining hands-on involvement in programming, validation, and technical oversight. This 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. \n

\n Responsibilities: \n \n

• Lead study-level statistical programming activities, including planning, prioritization, timeline management, risk identification, and status reporting.\n
• Develop, program, and validate SDTM and ADaM datasets, tables, listings, and figures using SAS and, where appropriate, R.\n
• Collaborate closely with Biostatistics, Data Management, Clinical Operations, and other cross-functional teams to clarify requirements and resolve data, programming, and specification issues.\n
• 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.\n
• 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.\n
• Support clinical study publications, regulatory submissions, health authority requests, and inspection-readiness activities.\n
• Monitor programming deliverables, dependencies, timelines, and risks, escalating significant issues and developing solutions as needed.\n
• Partner with cross-functional stakeholders and external vendors to ensure programming activities remain aligned with study requirements and project timelines.\n

• Bachelor’s degree in Statistics, Biostatistics, Computer Science, Mathematics, Life Sciences, or a related quantitative discipline.\n
• Minimum of 8+ years statistical programming experience in Biotech, Pharma, or CRO industry.\n
• Strong knowledge of CDISC standards, including SDTM and ADaM.\n
• Experience overseeing vendor deliverables and supporting regulatory submissions.\n