Lead Statistical Programmer – Early-Phase (SAS/ADaM)

NCBiotech; Durham (NC); On-site; USD 90,000 - 220,000; Full time

Job summary

IQVIA in Durham, NC is seeking an experienced Senior Statistical Programmer to lead regulatory submissions and develop SDTM/ADaM datasets for early-phase trials, including safety, PK, and PK/PD analyses. The role requires expert SAS programming, hands-on CDISC SDTM/ADaM/TLFs expertise, and strong communication to manage multiple priorities within a fast-paced CRO environment.

Ideal candidates will have 8+ years in pharmaceutical or CRO settings, prior lead programmer experience, and comfort

Qualifications

• 8+ years of statistical programming experience in pharmaceutical or CRO.
• Lead Programmer or technical lead experience.
• Experience in an FSP engagement model preferred.
• Experience supporting regulatory submissions required.
• Strong communication and stakeholder management skills.
• Independent, detail-oriented with ability to manage multiple priorities.
• Preferred: Translational Medicine or Clinical Pharmacology exposure.
• Exposure to integrated summaries or pooled PK analyses.

Skills

SAS programming

CDISC SDTM/ADaM

ADaM PK/PD

ER dataset creation

Early-phase designs

FSP experience

Regulatory submissions

Tools

SAS

Job description

IQVIA in Durham, NC is seeking an experienced Senior Statistical Programmer to lead regulatory submissions and develop SDTM/ADaM datasets for early-phase trials, including safety, PK, and PK/PD analyses. The role requires expert SAS programming, hands-on CDISC SDTM/ADaM/TLFs expertise, and strong communication to manage multiple priorities within a fast-paced CRO environment.

Ideal candidates will have 8+ years in pharmaceutical or CRO settings, prior lead programmer experience, and comfort