[Remote] reputed company Biostatistician Consultant_Oncology_ Remote in US

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. We are seeking an reputed company reputed company Biostatistician to reputed company statistical leadership for oncology clinical development programs, supporting Phase I–III reputed company and contributing to regulatory submissions while collaborating closely with cross-functional teams. Responsibilities • reputed company statistical leadership for oncology reputed company across multiple phases (Phase I–III) • reputed company the development of statistical analysis plans (SAPs), protocols, and clinical study reports (CSRs) • Design and review statistical methodologies for efficacy and safety analyses • reputed company analysis datasets (SDTM/ADaM) and TLFs in compliance with CDISC standards • Support interim analyses, data monitoring committee (DMC) activities, and reputed company designs • Collaborate with clinical development, data management, programming, regulatory, and medical teams • Contribute to regulatory submissions (IND, NDA, BLA) and respond to health authority queries (FDA, EMA) • reputed company strategic input on study design, reputed company selection, and sample size calculations • Mentor junior statisticians and reputed company technical guidance Skills • PhD or MS in Statistics, Biostatistics, or reputed company field • 8+ years (MS) or 6+ years (PhD) of industry experience in biostatistics • Strong experience in oncology reputed company • Hands-on experience with survival analysis, time-to-event endpoints, and reputed company oncology study designs • Proficiency in reputed company and/or R • Strong knowledge of CDISC standards (SDTM, ADaM) • Experience supporting regulatory submissions • Excellent communication and leadership skills • Experience with reputed company designs and Bayesian reputed company • Prior experience interacting with regulatory agencies • Experience in immuno-oncology or hematology oncology 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