Principal Statistical Programmer — Lead CDISC Submissions

IQVIA; Durham (NC); Sur place; USD 98 000 - 273 000; Plein temps

Résumé du poste

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.

The Principal Programmer 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 base SAS and advanced SAS including macros.
• In-depth knowledge of CDISC standards, regulatory guidelines, and submission requirements.
• Proven ability to manage complex studies independently from start to finish.

Responsabilités

• Provide end-to-end statistical programming support for clinical studies from setup through submission.
• Lead development and validation of programming deliverables.
• Ensure all 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 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 compliant, timely solutions.

Connaissances

Statistical programming

SAS (Base/Advanced)

CDISC standards

Regulatory submissions

Leadership/mentoring

Study management

Formation

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

Outils

SAS Base

SAS Advanced

SAS Macros

Description du poste

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.

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