Principal Statistical Programmer /Analyst Consultant - Remote in US at Clinchoice

Clinchoice

United States·6h ago

LeadFull-time

Salary Range

$153,000 - $207,000 /year

Estimated

This salary is estimated based on similar roles. The actual salary may vary.

About the Role

ClinChoice is searching for a Principal Statistical Programmer Consultant to join one of their clients. This role will serve as a senior technical expert responsible for end-to-end programming deliverables, study leadership, and oversight of internal teams and external vendors.

Key Responsibilities

→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.
→Work closely with Biostatistics, Data Management, Medical Writing, and Regulatory Affairs.
→Coordinate with CROs and external vendors, ensuring compliance, quality, and adherence to client programming standards.
→Prepare submission-ready programming outputs and documentation, including define.xml, annotated CRFs, and reviewer guides.
→Ensure all programming meets regulatory requirements (FDA, EMA, PMDA).

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 (hematologic or solid tumors).
✓Experience supporting regulatory submissions and preparing submission-ready outputs.
✓Excellent communication skills and ability to collaborate cross-functionally.