The Bioinformatics Statistician supports statistical analysis, model development, assay validation, regulatory submissions, and research collaborations across the Bioinformatics organization. This role works closely with Bioinformatics, Assay Development, Clinical Operations, Quality/Regulatory, and external collaborators to ensure analyses are scientifically rigorous, reproducible, and appropriate for regulated clinical applications.
KEY RESPONSIBILITIES
• Support statistical analyses for clinical and analytical validation studies required for regulatory, accreditation, or reimbursement needs, including CLIA/CAP, MolDx, and CE-IVDR.
• Develop and review statistical analysis plans, performance metrics, confidence intervals, acceptance criteria, and sample size assumptions.
• Provide statistical guardrails during assay and algorithm development, including QC metrics, decision thresholds, model assumptions, and robustness checks.
• Contribute to statistical analysis, model building, and algorithm improvements for MRD models and related clinical bioinformatics applications.
• Perform additional analyses to support new research initiatives, product development, and scientific strategy.
• Provide statistical review and validation for manuscripts, abstracts, presentations, and collaborator-led studies.
• Communicate statistical methods, results, risks, and recommendations clearly to technical and non-technical stakeholders.
Requirements
• Ph.D. in Statistics, Biostatistics, Bioinformatics, Computational Biology, Applied Mathematics, Data Science, or a related quantitative field.
• 5+ years of relevant industry, postdoctoral, or applied research experience.
• Strong statistical background with hands-on experience supporting regulated diagnostics, clinical validation, or analytical validation.
• Experience with model building, algorithm development, machine learning, probabilistic modeling, or related quantitative methods.
• Publication experience, including statistical support for manuscripts, abstracts, or external scientific collaborations.
• Proficiency with Python, R, or comparable statistical programming tools.
PREFERRED EXPERIENCE
• Experience with CLIA/CAP, MolDx, CE-IVDR, FDA, or comparable regulated environments.
• Experience with NGS, WGS, liquid biopsy, oncology diagnostics, or MRD testing.
• Familiarity with clinical assay development, diagnostic algorithms, validation documentation, and cross-functional regulated product development.