Biostatistician II

Role: Biostatistician II responsible for statistical expertise and management of analytical validation, clinical studies, and regulatory submissions for FMI’s diagnostic devices, including oncology companion diagnostics. Responsibilities: design and analyze validation studies using NGS-based diagnostics; develop innovative statistical solutions; collaborate with cross-functional teams on study design, data analysis, and regulatory responses; contribute to regulatory submissions and scientific publications; ensure high-quality, timely analysis and reporting; represent FMI in regulatory meetings and maintain biostatistics standards. Qualifications: Master’s in Statistics/Biostatistics with 4+ years or PhD with 2+ years of experience; strong R programming skills; experience with clinical study design, validation of diagnostics, genomics, and RWD analysis preferred. HighValue: diagnostics, oncology, NGS, clinical validation, regulatory submissions, biostatistics in biopharma, R&D, or diagnostics industry, familiarity with FDA interactions. WorkSetup: Remote, with salary range ~$125K–$156K, plus bonus and benefits.