Principal Statistical Programmer

Responsibilities

• Provide end-to-end statistical programming support for clinical studies from study setup through submission
• Lead and perform development and validation of SDTM datasets, ADaM datasets, and Tables, Listings, and Figures (TLFs)
• Ensure all deliverables are compliant with CDISC standards and regulatory requirements
• Support regulatory submissions (e.g., FDA, EMA), including define.xml, submission-ready datasets, and reviewer’s guides
• Provide technical leadership and guidance to other programmers as a subject matter expert
• Contribute to and maintain programming standards, macros, and validation processes
• Review and approve programming deliverables to ensure accuracy, consistency, and quality
• Collaborate with Biostatistics, Data Management, Clinical Operations, and Regulatory teams

Requirements

• Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related field
• Extensive experience as a statistical programmer with demonstrated Principal-level responsibilities
• Expert proficiency in base SAS and Advanced SAS, including hands-on experience with SAS Macros
• In-depth knowledge of CDISC standards, regulatory guidelines, and submission requirements
• Proven experience with SDTM and ADaM dataset development
• Extensive experience with TLF programming and regulatory submission deliverables
• Proven ability to manage complex studies independently from start to finish

About the Company

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.