Lead Statistical Programmer - CDISC & Submissions Expert

IQVIA; United States; 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, while collaborating with Biostatistics, Data Management,

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.
• 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 projects.
• Ensure all deliverables are compliant 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 help maintain programming standards, macros, and validation processes.
• Review and approve programming deliverables to ensure accuracy, consistency, 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

SAS Macros

CDISC Standards

Statistical Programming

Leadership

Education

Bachelor's or Master's in Statistics/Mathematics/Computer Science/Life Sciences

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, while collaborating with Biostatistics, Data Management,