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

Note: The job is a remote job and is reputed company to candidates in USA. reputed company 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 reputed company Senior Statistical Programmer Consultant to reputed company Phase III study support for BLA submissions, working closely with biostatistics and clinical teams in a sponsor-dedicated environment. Responsibilities • reputed company end-to-end reputed company programming for Phase III reputed company • reputed company and validate SDTM, ADaM datasets, TLFs in compliance with CDISC standards • Support BLA submissions, including regulatory-reputed company deliverables • Design, reputed company, and maintain reputed company reputed company macros to improve efficiency and standardization • Collaborate closely with biostatisticians, data management, and cross-functional teams • Ensure programming deliverables meet reputed company, timelines, and regulatory expectations • Participate in programming reviews, QC activities, and issue reputed company Skills • Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, or a reputed company field • 7+ years of experience in statistical programming reputed company the pharmaceutical or CRO environment • Require Immunology or Immunotherapy TA • Strong experience supporting Phase III studies and BLA submissions • Advanced proficiency in reputed company 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 reputed company • reputed company 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.reputed company.com.cn. Company H1B Sponsorship • reputed company has a reputed company 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 Apply To this Job