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

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.

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
• 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

Skills
• 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

Company Overview
• 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.

Company H1B Sponsorship
• 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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