Lead Statistical Programmer for SDTM/ADaM Submissions

IQVIA; 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 lead development and validation of SDTM/ADaM datasets and TLFs, ensure CDISC compliance, and support regulatory submissions (FDA/EMA).

Qualifications

• Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or related field
• Extensive experience as a statistical programmer, with demonstrated Principal‑level responsibilities
• Strong hands‑on experience with: SDTM and ADaM dataset development; TLF programming; Regulatory submission deliverables
• Expert proficiency in base SAS and Advanced SAS with good hands on 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 datasets; ADaM datasets; Tables, Listings, and Figures (TLFs)
• Ensure all deliverables are compliant with CDISC standards and regulatory requirements
• Support regulatory submissions (e.g., FDA, EMA), including define.xml, submission‑ready datasets, and reviewer’s guides
• Serve as a Principal‑level programmer, providing technical leadership and guidance to other programmers as needed
• Contribute to and help maintain programming standards, macros, and validation processes
• Review and approve programming deliverables to ensure accuracy, consistency, and quality
• Collaborate closely with Biostatistics, Data Management, Clinical Operations, and Regulatory teams
• Proactively identify risks and propose efficient, compliant solutions within timelines

Skills

SDTM

ADaM

TLF programming

Regulatory submissions

Base SAS

Advanced SAS

SAS Macros

CDISC standards

Leadership

Education

Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, Life Sciences, or related field

Tools

SAS

Define.xml

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 lead development and validation of SDTM/ADaM datasets and TLFs, ensure CDISC compliance, and support regulatory submissions (FDA/EMA).