[Remote] Senior Statistical Programmer Consultant (Oncology) Remote
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 Senior Statistical Programmer Consultant to lead programming activities for oncology clinical trials, ensuring compliance with regulatory standards and overseeing project deliverables.ResponsibilitiesLead programming activities for oncology clinical trials across multiple studiesDevelop, validate, and maintain SDTM and ADaM datasets following CDISC guidelinesOversee production of Tables, Listings, and Figures (TLFs) for study reporting and submissionsProvide SAS programming expertise to support complex data derivations and analysesReview and ensure traceability, consistency, and quality of all programming deliverablesAct as programming lead for assigned studies, managing timelines and deliverablesWork closely with Biostatistics, Data Management, Medical Writing, and Regulatory AffairsCoordinate with CROs and external vendors, ensuring compliance, quality, and adherence to client programming standardsSupport integrated analyses including ISS/ISEPrepare submission-ready programming outputs and documentation, including define.xml, annotated CRFs, and reviewer guidesEnsure all programming meets regulatory requirements (FDA, EMA, PMDA)Contribute to responses for regulatory queries and data requestsSkillsBachelor's or Master's degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field8–12+ years of statistical programming experience in pharma/biotech or CROExpert-level proficiency in SASStrong understanding of CDISC SDTM and ADaM standardsSignificant experience supporting oncology clinical trials (hematologic or solid tumors)Experience supporting regulatory submissions and preparing submission-ready outputsExcellent communication skills and ability to collaborate cross-functionallyCompany OverviewClinChoice 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 SponsorshipClinChoice has a track record of offering H1B sponsorships, with 2 in 2026, 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.