Principal Statistical Programmer
IQVIA
Summary
We are seeking a Principal Statistical Programmer to provide full end-to-end statistical programming support across clinical development programs. This role requires deep technical expertise, leadership, and hands-on delivery, covering SDTM, ADaM, TLF development, and regulatory submission support. The Principal Statistical Programmer will serve as a subject matter expert, ensure high-quality deliverables, and contribute to programming standards and best practices.
Job description
Position Summary
We are seeking a Principal Statistical Programmer to provide full end-to-end statistical programming support across clinical development programs. This role requires deep technical expertise, leadership, and hands-on delivery, covering SDTM, ADaM, TLF development, and regulatory submission support. The Principal Statistical Programmer will serve as a subject matter expert, ensure high-quality deliverables, and contribute to programming standards and best practices.
Key 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
- Serve as a Principal-level programmer, providing technical leadership and guidance to other programmers as needed
- Contribute to and help maintain programming standards, macros, and validation processes
- Review and approve programming deliverables to ensure accuracy, consistency, and quality
- Collaborate closely with Biostatistics, Data Management, Clinical Operations, and Regulatory teams
- Proactively identify risks and propose efficient, compliant solutions within timelines
Required Qualifications
- Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, Life Sciences, or related field
- Extensive experience as a statistical programmer, with demonstrated Principal-level responsibilities
- Strong hands-on experience with SDTM and ADaM dataset development
- Strong hands-on experience with TLF programming
- Strong hands-on experience with regulatory submission deliverables
- Expert proficiency in base SAS and Advanced SAS with good hands on SAS Macros
- In-depth knowledge of CDISC standards, regulatory guidelines, and submission requirements
- Proven ability to manage complex studies independently from start to finish
Requirements
- Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, Life Sciences, or related field
- Extensive experience as a statistical programmer, with demonstrated Principal-level responsibilities
- Strong hands-on experience with SDTM and ADaM dataset development
- Strong hands-on experience with TLF programming
- Strong hands-on experience with regulatory submission deliverables
- Expert proficiency in base SAS and Advanced SAS with good hands on SAS Macros
- In-depth knowledge of CDISC standards, regulatory guidelines, and submission requirements
- Proven ability to manage complex studies independently from start to finish
Benefits
- Health And Welfare Benefits
- Incentive Plans
- Bonuses
Company overview
IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. Headquartered in Durham, North Carolina, the company operates in over 100 countries with approximately 86,000 employees worldwide. IQVIA specializes in creating intelligent connections across all aspects of healthcare through its proprietary IQVIA Connected Intelligence platform, which combines analytics, transformative technology, big data resources, and extensive domain expertise. The company's comprehensive portfolio includes clinical trial management, real-world evidence generation, commercial insights, and regulatory compliance services. IQVIA serves a diverse client base including pharmaceutical manufacturers, biotechnology companies, medical device firms, government agencies, and healthcare providers. With its Healthcare-grade AI capabilities and extensive global data assets, IQVIA accelerates the development and commercialization of innovative medical treatments while improving healthcare outcomes for patients globally. The company is publicly traded on the New York Stock Exchange under the ticker symbol IQV.