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 who will provide oversight and technical leadership in statistical programming, ensuring high-quality deliverables and maintaining effective communication with clients and internal teams. Responsibilities • Provide oversight development of datasets (SDTMs/ADaMs) in CDISC-compliant format by CROs, including clear documentation of the process that was followed in the form of specifications, trackers, and checklists. • Generate and/or review SDTM mapping specifications, annotated CRFs, ADaM specifications, define.XML documents, and reviewers’ guides per CDISC and FDA specifications and guidelines. • Accountable for oversight of statistical programming deliverables for in-house and outsourced projects. • Provide technical leadership, problem-solving of moderate to high complexity, and within project timelines while providing high-quality deliverables. • Independently develop SAS or other programs and specifications for production of output to support study needs, including publications, safety reporting, and ad hoc analyses in a timely fashion. • Demonstrate expertise in SAS language, procedures, and options commonly used in clinical trial reporting, including the Macro language, BASE SAS, SAS/STAT & SAS/GRAPH. • Oversee and manage the work of other junior programmers. • Develop and/or validate standard macros to automate output production. • Adhere to company SOPs and department guidelines. • Work concurrently on multiple projects • Troubleshoot technical and project issues. • Help with the infrastructure development of the department. • Communicate effectively with internal cross-functional groups and external partners. Skills • At least 8 – 10 years of experience in statistical programming with clinical data and SAS • Strong SAS programming skills required with proficiency in SAS/Base, SAS/Stat and SAS/Macros • CDISC proficiency required • Knowledge of appropriate regulations, industry standards and guidance documents • Good interpersonal communication skills to collaborate effectively with internal cross-functional groups and external partners • Experience in Rare disease/Neurology therapeutic area is a plus • SAS/GRAPH experience (Kaplan-Meier plots, swim lane plots) strongly preferred Education Requirements • BS/BA degree in a related discipline Company Overview • ClinChoice is a Reaserch and Deveiopment platform, It develops a 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 18 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