Biostatistician I

Role: Biostatistician I supporting development, validation, and regulatory approval of FMI's diagnostic devices, particularly NGS-based oncology assays. Responsibilities: design and analyze analytical and clinical validation studies, develop statistical methodologies, write study protocols and reports, contribute to regulatory submissions, and liaise with regulatory agencies like the FDA. Collaborate with cross-functional teams on study planning, data analysis, and presentation of results, ensuring adherence to quality standards and timelines. Qualifications: Master’s in Statistics or Biostatistics with 2+ years’ experience or PhD; strong R programming skills. Preferred: PhD, industry or academic experience in biopharma, diagnostics, or regulatory settings; expertise in clinical study design, diagnostic validation, NGS/genomics, Bayesian methods, and real-world data analysis. High-value biopharma specifics: diagnostics validation, oncology applications, analytical and clinical validation, potential engagement with regulatory bodies. Work setup: remote; no travel specified.