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, biotechnology, medical device, and consumer health companies. They are seeking a Principal Statistical Programmer Consultant to provide technical leadership for oncology clinical trials, manage programming deliverables, and ensure compliance with regulatory requirements. 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 Kite’s 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 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. Apply tot his job