Lead Statistical Programmer — SDTM/ADaM & Submissions

IQVIA LLC; Durham (NC); On-site; USD 98,000 - 273,000; Full time

Job summary

IQVIA is seeking a Principal Statistical Programmer to provide full end-to-end statistical programming support across clinical development programs, covering SDTM, ADaM, TLF development, and regulatory submission activities.

The role demands deep technical expertise, leadership, and hands-on delivery, serving as a subject matter expert, ensuring high quality deliverables, and guiding programming standards, macros, validation processes, and collaboration with Biostatistics, Data Management,

Qualifications

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

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, 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.

Skills

Base SAS & Advanced SAS

SAS Macros

CDISC Standards

Regulatory Submissions

SDTM/ADaM

TLF Programming

Project Leadership

Study Management

Education

Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or related field

Tools

SAS

Job description

IQVIA is seeking a Principal Statistical Programmer to provide full end-to-end statistical programming support across clinical development programs, covering SDTM, ADaM, TLF development, and regulatory submission activities.

The role demands deep technical expertise, leadership, and hands-on delivery, serving as a subject matter expert, ensuring high quality deliverables, and guiding programming standards, macros, validation processes, and collaboration with Biostatistics, Data Management,