Lead Biostatistician
Core
Lead statistical support for clinical study design, analysis, and regulatory reporting for IVD molecular assays in oncology, infectious disease, and blood diagnostics.
Role type
Lead Biostatistician (Regulatory/IVD)
Builds
Qualitative and quantitative IVD molecular assays for blood biomarkers, hematology, infectious disease, and oncology applications.
Domain
Life Sciences / Diagnostics / Biotechnology
Deliverable
production ML models | dashboards & analysis | client delivery
Required skills
Statistical analysis (general linear modeling, survival analysis, multivariate classification), Sample size estimation, Regulatory guideline knowledge (FDA, CE-IVDR, WHO, CLSI), SAS, Python, R, Excel, Minitab, SOP development, Mentorship
Preferred skills
IVD regulatory submissions experience, FDA CDRH and CE interaction experience
Technologies
SAS, Python, R, Excel, Minitab
Responsibilities
Provide end-to-end statistical analysis support for IVD product life cycle development; Provide statistical input in clinical study designs including sample size estimates; Author statistical sections for clinical protocols, analysis plans, and reports submitted to regulatory agencies; Review and update standard operating procedures and provide statistical training; Provide expert biostatistics input for analytical studies (reproducibility, precision, LOD, method comparisons).
