Principal Statistical Programmer / Analyst Consultant - Remote

Overview

The Principal Statistical Programmer will serve as a senior technical expert responsible for end-to-end programming deliverables, study leadership, and oversight of internal teams and external vendors.

In Short

• Lead programming activities for oncology clinical trials across multiple studies.
• Develop, validate, and maintain SDTM and ADaM datasets following CDISC guidelines.
• Oversee production of Tables, Listings, and Figures (TLFs) for study reporting and submissions.
• Provide SAS programming expertise to support complex data derivations and analyses.
• Review and ensure traceability, consistency, and quality of all programming deliverables.
• Act as programming lead for assigned studies, managing timelines and deliverables.
• Coordinate with CROs and external vendors, ensuring compliance, quality, and adherence to client programming standards.
• Prepare submission-ready programming outputs and documentation.
• Ensure all programming meets regulatory requirements (FDA, EMA, PMDA).
• Excellent communication skills and ability to collaborate cross-functionally.

Requirements

• Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field.
• 8–12+ years of statistical programming experience in pharma/biotech or CRO.
• Expert-level proficiency in SAS.
• Strong understanding of CDISC SDTM and ADaM standards.
• Significant experience supporting oncology clinical trials.
• Experience supporting regulatory submissions and preparing submission-ready outputs.
• Excellent communication skills and ability to collaborate cross-functionally.

Benefits

• Career opportunities within a global CRO.
• Work directly for a single sponsor.
• Support a healthier and safer world through innovative drug development.
• Access to continuous training and development.
• Diversity and inclusivity in the workplace.