[Remote] Principal Biostatistician Consultant_Oncology_ Remote in US
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 an experienced Principal Biostatistician Consultant to provide statistical leadership for oncology clinical development programs, supporting Phase I–III clinical trials and contributing to regulatory submissions. Responsibilities • Provide statistical leadership for oncology clinical trials across multiple phases (Phase I–III) • Lead the development of statistical analysis plans (SAPs), protocols, and clinical study reports (CSRs) • Design and review statistical methodologies for efficacy and safety analyses • Oversee analysis datasets (SDTM/ADaM) and TLFs in compliance with CDISC standards • Support interim analyses, data monitoring committee (DMC) activities, and adaptive 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) • Provide strategic input on study design, endpoint selection, and sample size calculations • Mentor junior statisticians and provide technical guidance Skills • PhD or MS in Statistics, Biostatistics, or related field • 8+ years (MS) or 6+ years (PhD) of industry experience in biostatistics • Strong experience in oncology clinical trials • Hands-on experience with survival analysis, time-to-event endpoints, and complex oncology study designs • Proficiency in SAS and/or R • Strong knowledge of CDISC standards (SDTM, ADaM) • Experience supporting regulatory submissions • Excellent communication and leadership skills • Experience with adaptive designs and Bayesian methods • Prior experience interacting with regulatory agencies • Experience in immuno-oncology or hematology oncology 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.