Lead Statistical Programmer: SDTM/ADaM, TLFs & Submissions

IQVIA; Durham (NC); On-site; USD 98,000 - 273,000; Full time

Job summary

IQVIA seeks a Principal Statistical Programmer to provide full end-to-end statistical programming support across clinical development. The role covers SDTM, ADaM, TLF development, and regulatory submission support, with leadership and hands-on delivery.

You will lead development and validation of datasets, ensure CDISC compliance, and collaborate with Biostatistics, Data Management, Clinical Operations, and Regulatory teams. High-quality deliverables and standards are emphasized.

Qualifications

• Bachelor’s or Master’s degree in statistics, mathematics, computer science, life sciences, or related field.
• Extensive experience as a statistical programmer with principal-level responsibilities.
• Hands-on experience with SDTM/ADaM, TLF programming, and regulatory submission deliverables.

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, and TLFs.
• Ensure all deliverables are compliant with CDISC standards and regulatory requirements.
• Support regulatory submissions (e.g., FDA, EMA), including define.xml and reviewer’s guides.
• Serve as a Principal-level programmer, providing technical leadership to other programmers.

Skills

SAS programming

SDTM/ADaM

TLF development

Regulatory submissions

Leadership

Education

Bachelor's or Master's degree

Tools

SAS Macros

Job description

IQVIA seeks a Principal Statistical Programmer to provide full end-to-end statistical programming support across clinical development. The role covers SDTM, ADaM, TLF development, and regulatory submission support, with leadership and hands-on delivery.

You will lead development and validation of datasets, ensure CDISC compliance, and collaborate with Biostatistics, Data Management, Clinical Operations, and Regulatory teams. High-quality deliverables and standards are emphasized.