Lead Programmer Overview • The Lead Programmer will oversee clinical programming activities within a dynamic pharmaceutical environment. • Collaborate with cross-functional teams to deliver submission-ready clinical datasets and reporting outputs. • Utilize SAS programming expertise to support clinical studies and regulatory submissions. • Contribute to programming standards, reusable tools, templates, and process improvements. • Provide technical oversight of external programming vendors and mentor junior programmers. • Ensure compliance with CDISC standards, including SDTM and ADaM datasets. • Support regulatory submission activities, including define.xml and annotated CRFs. • Work in a hybrid environment offering flexibility and collaboration opportunities. Lead Programmer Key Responsibilities & Duties • Lead programming activities for assigned clinical studies and development programs. • Develop and validate CDISC-compliant datasets, tables, listings, and figures. • Translate protocols and statistical analysis plans into programming deliverables. • Collaborate with study teams to manage programming timelines and deliverables. • Review clinical data and vendor deliverables to ensure quality and compliance. • Perform programming QC, validation, documentation, and inspection-readiness activities. • Provide technical oversight of external programming vendors. • Contribute to programming standards and process improvements. Lead Programmer Job Requirements • Bachelor’s degree in Statistics, Biostatistics, Mathematics, Computer Science, or related field; advanced degree preferred. • 10+ years of SAS programming experience in pharmaceutical or clinical research settings. • Proficiency in Base SAS, SAS Macro language, PROC SQL, and clinical data-reporting procedures. • Extensive experience with CDISC standards, including SDTM and ADaM datasets. • Demonstrated experience supporting Phase I–III clinical trials and regulatory submissions. • Strong understanding of clinical-trial data, validation, and quality-control practices. • Experience managing multiple priorities and collaborating across functions. • Excellent communication, organizational, and problem-solving skills.