Staff Biostatistician

Role overview This position supports the design, analysis, and interpretation of clinical, observational, translational, and research studies with minimal guidance. The role owns defined statistical deliverables, develops statistical analysis plans, and partners with cross-functional stakeholders to ensure analyses are scientifically rigorous, reproducible, and clearly communicated. It sits within a clinical metagenomics organization focused on infectious disease diagnostics using cell-free DNA sequencing and machine learning.

Responsibilities - Independently perform statistical analyses for clinical studies, research initiatives, product development, and evidence-generation efforts. - Partner with clinical and scientific stakeholders to define study objectives, endpoints, hypotheses, and appropriate statistical methodologies. - Develop statistical analysis plans, including sample size and power calculations, analysis populations, statistical methods, and sensitivity analyses. - Analyze diagnostic performance measures such as sensitivity, specificity, predictive value, and agreement metrics, plus longitudinal data, survival outcomes, missing data, and subgroup analyses as appropriate. - Collaborate with data science, bioinformatics, clinical development, medical affairs, and R&D teams to ensure statistical rigor and appropriate interpretation of results. - Review datasets and analysis outputs for accuracy, completeness, consistency, and statistical validity, and maintain documentation of methodologies, assumptions, and results. - Contribute statistical content to study reports, abstracts, manuscripts, posters, presentations, and regulatory materials. - Develop reusable statistical programs, workflows, and documentation that support reproducible analyses and continuous improvement.

Requirements - Graduate degree in biostatistics, statistics, or a closely related quantitative field, with demonstrated experience independently leading statistical deliverables. - Strong applied expertise in regression, longitudinal modeling, survival analysis, missing-data methods, and handling of complex data structures. - Demonstrated ability to address highly complex, novel, or ambiguous problems and develop practical solutions. - Excellent communication skills with the ability to make complex statistical concepts accessible to non-technical audiences. - Strong collaboration and relationship-building skills across disciplines and organizational levels. - Demonstrated ability to mentor and develop other technical contributors. - High degree of ownership, initiative, and accountability, with a commitment to advancing statistical rigor and best practices.

Nice to have - Experience supporting regulatory submissions, clinical study reports, or peer-reviewed publications. - Familiarity with diagnostic validation studies, real-world evidence, or laboratory-derived biomarker data. - Working knowledge of R or SAS alongside standard statistical tooling.

Benefits and work setup - Remote position reporting to the Director of Clinical Statistics and Data Management. - Mission-driven environment where statistical work directly informs infectious disease diagnosis and treatment decisions.