Bioinformatics Statistician

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. 

• 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.