Principal Statistical Programmer

IQVIA; 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. This role requires deep technical expertise, leadership, and hands-on delivery, covering SDTM, ADaM, TLF development, and regulatory submission support.

You will lead development and validation of SDTM/ADaM datasets and TLFs, ensure CDISC compliance, and support regulatory submissions (FDA/EMA).

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; TLF programming; 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

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

SDTM

ADaM

TLF programming

Regulatory submissions

Base SAS

Advanced SAS

SAS Macros

CDISC standards

Leadership

Education

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

Tools

SAS

Define.xml

Job description

Job Title: Principal Statistical Programmer

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
  • 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
  • TLF programming
  • 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

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. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $98,200.00 - $273,200.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part‑time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.