[Remote] Principal Statistical Programmer /Analyst Consultant - Remote in US

🌍 Remote, USA 🎯 Full-time 🕐 Posted Recently

Job Description

Note: The job is a remote job and is open to candidates in USA. ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical and biotechnology companies. They are seeking a Principal Statistical Programmer Consultant responsible for end-to-end programming deliverables, study leadership, and oversight of internal teams and external vendors, particularly in oncology clinical trials.

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

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

ClinChoice is a Reaserch and Deveiopment platform that develops innovative drugs and devices. It was founded in 1995, and is headquartered in Shanghai, Shanghai, CHN, with a workforce of 1001-5000 employees. Its website is https://www.clinchoice.com.cn.

ClinChoice has a track record of offering H1B sponsorships, with 20 in 2025, 28 in 2024, 21 in 2023, 25 in 2022, 35 in 2021, 3 in 2020. Please note that this does not guarantee sponsorship for this specific role.

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