ClinChoice

Principal Statistical Programmer – Analyst Consultant

ClinChoice

full-time

Posted on:

Location Type: Remote

Location: United States

Visit company website

Explore more

✨ AI Apply
Apply

Job Level

Lead

About the role

  • 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.
  • Support integrated analyses including ISS/ISE.
  • Prepare submission-ready programming outputs and documentation, including define.xml, annotated CRFs, and reviewer guides.
  • Ensure all programming meets regulatory requirements (FDA, EMA, PMDA).
  • Contribute to responses for regulatory queries and data requests.

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.
Benefits
  • Health insurance
  • Retirement plans
  • Paid time off
  • Flexible work arrangements
  • Professional development
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
SASSDTMADaMstatistical programmingdata derivationsregulatory submissionsprogramming outputsdefine.xmlannotated CRFsreviewer guides
Soft Skills
communicationcollaborationleadershipproject managementquality assuranceproblem-solvingattention to detailtime managementcross-functional teamworkregulatory compliance