Principal Statistical Programmer

We are 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.

Key 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, and Tables, Listings, and Figures (TLFs)
• Ensure all 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 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

Required 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, and 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

The potential base pay range for this role, when annualized, is $98,200.00 - $273,200.00.