Senior Statistical Programmer & CDISC Submissions Lead

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

Job summary

IQVIA is seeking a Principal Statistical Programmer to lead end-to-end statistical programming across clinical programs. The role covers SDTM, ADaM, TLF development, and regulatory submission support, serving as a subject matter expert and driving best practices.

The candidate will collaborate with Biostatistics, Data Management, Clinical Operations, and Regulatory teams to ensure high-quality, submission-ready deliverables while advancing programming standards and macros.

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 experience.
• Regulatory submission deliverables experience.
• In-depth knowledge of CDISC standards, regulatory guidelines, and submission requirements.

Responsibilities

• Provide end-to-end statistical programming support for clinical studies from setup through submission.
• Lead and perform development and validation of SDTM datasets, ADaM datasets, and TLFs.
• Ensure deliverables are compliant with CDISC standards and regulatory requirements.
• Support regulatory submissions including define.xml, submission-ready datasets, and reviewer’s guides.
• Serve as a Principal-level programmer providing technical leadership to other programmers.
• Contribute to programming standards, macros, and validation processes.
• Review and approve programming deliverables for accuracy and consistency.
• Collaborate with Biostatistics, Data Management, Clinical Operations, and Regulatory teams.

Skills

Statistical programmer

Principal-level responsibilities

SDTM & ADaM development

TLF programming

Regulatory submission deliverables

SAS/macros

Education

Bachelor’s or Master’s degree in Statistics/Mathematics/CS/Life Sciences

Tools

SAS Macros

Job description

IQVIA is seeking a Principal Statistical Programmer to lead end-to-end statistical programming across clinical programs. The role covers SDTM, ADaM, TLF development, and regulatory submission support, serving as a subject matter expert and driving best practices.

The candidate will collaborate with Biostatistics, Data Management, Clinical Operations, and Regulatory teams to ensure high-quality, submission-ready deliverables while advancing programming standards and macros.