ClinChoice is hiring a Principal Statistical Programmer Consultant to serve as a senior technical expert for oncology clinical trials. In this role, you will be responsible for end-to-end programming, study leadership, and oversight, using advanced SAS expertise and deep knowledge of CDISC standards to support regulatory submissions and contribute to our mission of accelerating the development of innovative drugs.
What You'll Do
- 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 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.
What We're Looking For
- Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or a related field.
- 8–12+ years of statistical programming experience in pharma/biotech or a 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.
Technical Stack
- SAS
- R
- CDISC SDTM
- CDISC ADaM
Team & Environment
You will work closely with Biostatistics, Data Management, Medical Writing, and Regulatory Affairs, and coordinate with CROs and external vendors.
Work Mode
This is a remote position open to candidates based in the United States.
ClinChoice is an equal opportunity employer.





