We are seeking a highly experienced Senior SAS Programmer. This role requires extensive hands-on expertise in programming and statistics, specifically in the creation and review of SDTM/ADaM datasets and TLF outputs. You will bring over 10 years of relevant experience, coupled with a proven track record in managing studies and leading project teams.

Key Responsibilities:

• Data Standards & Development: Ensure CRFs comply with protocol guidelines, develop and review SDTM/ADaM specifications, and build datasets from clinical databases. Create SAS macros, templates, and utilities for data cleaning and reporting.
• Clinical Trial Programming & Analysis: Execute all necessary SAS and R programming for clinical trial analysis and reporting, including validating datasets, tables, listings, and figures. Perform statistical analyses and prepare clinical and statistical summary reports.
• Quality Assurance & Compliance: Conduct thorough quality control on all statistical programming deliverables, ensuring adherence to departmental SOPs and regulatory guidelines (including CDISC packages for e-submission).
• Project Leadership & Collaboration: Lead discussions and activities related to statistical reporting, maintain project plans, and track deliverables. Work closely with Biostatistics and Data Management teams, providing guidance and support to ensure high-quality and timely outputs within a study/project.
• Process Improvement: Identify opportunities for standard utility macro development and contribute to process improvements, automation, and best practices based on lessons learned.

Experience

• Over 10 years of hands-on experience in SAS programming and statistics for clinical trial data.
• Demonstrable expertise in SDTM/ADaM dataset creation and review, and TLF generation.
• Proven experience in managing studies and leading programming teams.
• Strong understanding of CDISC standards (SDTM, ADaM, define.xml) and regulatory submission requirements.
• Excellent communication, analytical, and problem-solving skills.
• A meticulous approach to quality control and documentation.
• Any experience of R programming will be a plus, but not essential

This is a fully remote role based in the US, working with EST timezone.