Principal Statistical Programmer

IQVIA•Durham, NC

23h

About The Position

Program Leadership: Lead statistical programming across multiple trials or programs; guide both internal and external teams. Team & Line Management: Mentor junior staff; act as functional manager for associates; represent Statistical Programming at governance meetings. Technical Expertise: Strong SAS, R, CDISC SDTM/ADaM/Define.xml, eCTD knowledge; familiarity with eCRF/data structures. Deliverable Quality: Ensure QC, validation, audit readiness, and regulatory inspection readiness; deliver datasets and outputs for CSRs, safety reports, publications. Cross-functional Collaboration: Partner with clinical, statistical, HEOR, and IT teams; coordinate with external vendors. Innovation & Process Improvement: Lead process improvements, apply new analytics capabilities, HTA/HEOR solutions, advanced tools (R/Shiny, automation). Qualifications & Experience Education: Advanced degree in Statistics, Computer Science, Biostatistics, Life Sciences, or related field. Experience: 10+ years in statistical programming within pharma/biotech; expertise across clinical trial Phases I–IV, regulatory submissions, CDISC, RWE, HEOR, HTA. Technical Skills: Proficient in SAS & R; Python, Shiny preferred; solid understanding of clinical data standards. Soft Skills: Strong leadership, mentorship, presentation, and negotiation skills; problem-solving ability and judgment in regulatory/technical contexts. 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 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.

Requirements

Advanced degree in Statistics, Computer Science, Biostatistics, Life Sciences, or related field
10+ years in statistical programming within pharma/biotech
Expertise across clinical trial Phases I–IV, regulatory submissions, CDISC, RWE, HEOR, HTA
Proficient in SAS & R
Solid understanding of clinical data standards
Strong leadership, mentorship, presentation, and negotiation skills
Problem-solving ability and judgment in regulatory/technical contexts
Strong SAS, R, CDISC SDTM/ADaM/Define.xml, eCTD knowledge
Familiarity with eCRF/data structures

Nice To Haves

Python, Shiny preferred

Responsibilities

Lead statistical programming across multiple trials or programs
Guide both internal and external teams
Mentor junior staff
Act as functional manager for associates
Represent Statistical Programming at governance meetings
Ensure QC, validation, audit readiness, and regulatory inspection readiness
Deliver datasets and outputs for CSRs, safety reports, publications
Partner with clinical, statistical, HEOR, and IT teams
Coordinate with external vendors
Lead process improvements
Apply new analytics capabilities, HTA/HEOR solutions, advanced tools (R/Shiny, automation)