Lead Programmer

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.