Biostatistician II

Role: Biostatistician II responsible for statistical expertise in the development, validation, and regulatory approval of FMI’s diagnostic devices, including companion diagnostics in oncology. Responsibilities include designing and analyzing analytical and clinical validation studies for NGS-based diagnostics, developing innovative statistical solutions, collaborating cross-functionally on study design, data analysis, and regulatory submissions, and ensuring high-quality, timely deliverables. Qualifications: Master’s in Statistics/Biostatistics with 4+ years or PhD with 2+ years of relevant experience; strong R programming skills. Preferred: PhD in Biostatistics with experience in diagnostics, clinical trial design, NGS/genomics, real-world data, statistical methods in diagnostic medicine, and regulatory interactions (FDA). High-Value: Focus on oncology diagnostics, analytical/clinical validation, NGS/genomics, regulatory submissions, and collaborative scientific communication. WorkSetup: Remote; salary range $125K–$156K, with bonus and benefits.