[Remote] Senior Statistical Programmer/Analyst Consultant- Oncology (require -BLA Submission and Macro)

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 an experienced Senior Statistical Programmer Consultant to provide Phase III study support for BLA submissions, working closely with biostatistics and clinical teams in a sponsor-dedicated environment. Responsibilities • Perform end-to-end SAS programming for Phase III clinical trials • Develop and validate SDTM, ADaM datasets, TLFs in compliance with CDISC standards • Support BLA submissions, including regulatory-ready deliverables • Design, develop, and maintain complex SAS macros to improve efficiency and standardization • Collaborate closely with biostatisticians, data management, and cross-functional teams • Ensure programming deliverables meet quality, timelines, and regulatory expectations • Participate in programming reviews, QC activities, and issue resolution Skills • Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, or a related field • 7+ years of experience in statistical programming within the pharmaceutical or CRO environment • Require Immunology or Immunotherapy TA • Strong experience supporting Phase III studies and BLA submissions • Advanced proficiency in SAS programming, including macro development • Solid understanding of CDISC standards (SDTM, ADaM) • Experience working in an FSP or sponsor-dedicated model is highly preferred • Oncology is a plus • Experience working directly with sponsor teams • Exposure to regulatory interactions and submission timelines 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