Senior Biostatistician

Role: Lead biostatistician for development and regulatory approval of FMI’s diagnostic devices, including companion diagnostics in oncology, focusing on NGS-based assays. Responsibilities: independently design and analyze analytical and clinical validation studies, develop statistical methodologies, write protocols and reports, collaborate cross-functionally on study planning and regulatory submissions, mentor junior team members, and represent FMI in regulatory meetings. Qualifications: Master’s in Statistics/Biostatistics with 5-7+ years, or PhD with 3-5+ years relevant experience; expert in R programming. Preferred: PhD with 5+ years in biopharma/diagnostics, experience with clinical trial design, diagnostic validation, NGS/genomics, and real-world data; strong leadership, communication, and project management skills. HighValue: diagnostics, companion diagnostics, oncology, NGS, analytical/clinical validation, regulatory submissions, cross-functional collaboration. WorkSetup: Remote, with salary range $145K-$179K, plus bonus and benefits.