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 10years 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 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 10years 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.
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