Associate Principal Statistical Programmer, PKPD

IQVIA; Durham (NC); On-site; USD 88,000 - 221,000; Full time

Job summary

IQVIA in Durham, NC seeks a senior statistical programmer with 8+ years in pharma/CRO to lead development of SDTM/ADaM datasets and TLFs for early-phase studies.

You will design and validate PK/PD datasets, support POPPK/ER workflows, and contribute to regulatory submissions. Strong communication and independence are essential in this lead role.

Qualifications

• 8+ years of statistical programming in pharma/CRO environments.
• Demonstrated experience as a Lead Programmer or technical lead.
• Expert-level SAS programming skills.
• Experience supporting regulatory submissions.

Skills

SAS programming

CDISC SDTM

ADaM

TLFs

PK/PD ADaM datasets

POPPK/POP PD/ER workflows

Early-phase trial designs

PK parameter pooling

Job description

• Strong, hands‑on experience with CDISC SDTM, ADaM and TLFs.
• Proven experience developing safety, PK, and PK/PD ADaM datasets.
• Experience supporting POPPK/popPD/Exposure Response(ER) dataset creation workflows.
• Solid understanding of early‑phase clinical trial designs, including:
• PK parameter pooling

Technical Skills

Required Skills & Experience

• Expert‑level SAS programming skills.
• Strong, hands‑on experience with CDISC SDTM, ADaM and TLFs.
• Proven experience developing safety, PK, and PK/PD ADaM datasets.
• Experience supporting POPPK/popPD/Exposure Response(ER) dataset creation workflows.
• Solid understanding of early‑phase clinical trial designs, including:
• Phase I / First‑in‑Human
• Crossover studies
• Exposure–response analysis
• PK parameter pooling

Experience

• 8+ years of statistical programming experience in the pharmaceutical or CRO environment.
• Demonstrated experience as a Lead Programmer or technical lead.
• Prior experience working in an FSP engagement model preferred.
• Experience supporting regulatory submissions is required.

Soft Skills

• Strong communication and stakeholder management skills.
• Ability to work independently while managing multiple priorities.
• Detail‑oriented with a strong commitment to quality and timelines.

Preferred Qualifications

• Experience supporting Translational Medicine or Clinical Pharmacology groups.
• Familiarity with internal exploratory analysis and early‑phase decision‑making needs.
• Exposure to integrated summaries or pooled PK analyses across studies.

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 $88,300.00 - $220,900.00. 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.