Principal Statistical Programmer — End-to-End CDISC Lead

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

Job summary

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

You will serve as a subject matter expert, ensure high-quality deliverables, and contribute to programming standards and best practices.

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.
• Strong hands-on experience with SDTM and ADaM dataset development, TLF programming.
• Expert proficiency in Base SAS and Advanced SAS with SAS Macros.
• In-depth knowledge of CDISC standards, regulatory guidelines, and submission requirements.
• Proven ability to manage complex studies independently from start to finish.

Responsibilities

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

Skills

SDTM development

ADaM development

TLF programming

Regulatory submissions

SAS programming

Leadership

CDISC standards

Education

Bachelor’s or Master’s in Statistics/Math/CS/Life Sciences

Tools

Base SAS

Advanced SAS

SAS Macros

Job description

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

You will serve as a subject matter expert, ensure high-quality deliverables, and contribute to programming standards and best practices.