Principal Statistical Programmer: Lead SDTM/ADaM

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

Job summary

IQVIA is seeking a Principal Statistical Programmer to provide end-to-end statistical programming support across clinical development programs. The role requires deep technical expertise, leadership, and hands-on delivery covering SDTM, ADaM, and TLF development for regulatory submissions.

The successful candidate will act as a subject matter expert, ensure high-quality deliverables, lead programming standards, and collaborate with cross-functional teams to manage risks and deliver compliant

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 SDTM and ADaM dataset development and TLF programming.

Responsibilities

• Provide end-to-end statistical programming support for clinical studies from study setup through submission.
• Lead development and validation of: SDTM datasets, ADaM datasets, and TLFs.
• Ensure deliverables are compliant with CDISC standards and regulatory requirements.
• Support regulatory submissions (e.g., FDA, EMA), including define.xml and submission-ready datasets.
• Serve as a Principal-level programmer, providing technical leadership and guidance to other programmers.
• Contribute to and help maintain programming standards, macros, and validation processes.
• Review and approve programming deliverables to ensure accuracy and quality.
• Collaborate with Biostatistics, Data Management, Clinical Operations, and Regulatory teams.
• Proactively identify risks and propose compliant solutions within timelines.

Skills

Base SAS

Advanced SAS with macros

CDISC standards

Regulatory submission support

Leadership

Education

Bachelor's degree in Statistics or related field

Master's degree in Statistics or related field

Tools

SAS

SAS Macros

CDISC Define.xml

Job description

IQVIA is seeking a Principal Statistical Programmer to provide end-to-end statistical programming support across clinical development programs. The role requires deep technical expertise, leadership, and hands-on delivery covering SDTM, ADaM, and TLF development for regulatory submissions.

The successful candidate will act as a subject matter expert, ensure high-quality deliverables, lead programming standards, and collaborate with cross-functional teams to manage risks and deliver compliant