Lead Statistical Programmer: CDISC & Submissions Expert

IQVIA LLC; Durham, Northern (NC, KY); Hybrid; USD 98,000 - 273,000; Full time

Job summary

IQVIA LLC in Durham, NC seeks a Principal Statistical Programmer to provide full end-to-end statistical programming for clinical development programs. This role requires leadership, hands-on delivery, and expertise in SDTM/ADaM, TLF development, and regulatory submission support.

You will lead development, validation, and review of datasets and tables, listings, and figures, ensuring CDISC standards and regulatory guidelines are met, and collaborate with cross-functional teams in Durham, NC.

Qualifications

• Experience as statistical programmer at principal level in clinical studies.
• Strong SDTM/ADaM dataset development and TLF programming.
• Experience with regulatory submissions and define.xml.

Responsibilities

• Lead end-to-end programming for studies from setup to submission.
• Develop and validate SDTM/ADaM datasets and TLFs.
• Ensure CDISC compliance and regulatory guidelines; provide technical leadership.

Skills

SDTM development

ADaM development

TLF programming

Regulatory submissions

SAS programming

CDISC standards

Education

BSc/MSc in Statistics/Math/CS/Life Sciences

Tools

Base SAS

Advanced SAS

SAS Macros

Job description

IQVIA LLC in Durham, NC seeks a Principal Statistical Programmer to provide full end-to-end statistical programming for clinical development programs. This role requires leadership, hands-on delivery, and expertise in SDTM/ADaM, TLF development, and regulatory submission support.

You will lead development, validation, and review of datasets and tables, listings, and figures, ensuring CDISC standards and regulatory guidelines are met, and collaborate with cross-functional teams in Durham, NC.