Senior Biostatistician
Core
Provide end-to-end statistical support for clinical study design, analysis, and regulatory reporting for IVD molecular assays in infectious disease, hematology, and oncology.
Role type
Senior Biostatistician (Regulatory & Clinical Studies)
Builds
Regulatory submissions (FDA, CE-IVDR) for qualitative and quantitative IVD molecular assays
Domain
Life Sciences / Diagnostics / Biotechnology
Deliverable
production ML models | dashboards & analysis
Required skills
Statistical analysis (general linear modeling, survival analysis, multivariate classification), Sample size estimation, Protocol and analysis plan authoring, SOP development, Analytical study design (reproducibility, precision, LOD, accuracy, linearity), Regulatory guideline knowledge (FDA, CE-IVDR, WHO, CLSI), SAS, Python, R, Minitab, Excel
Preferred skills
IVD regulatory submission experience, FDA CDRH and CE interaction experience
Technologies
SAS, Python, R, Minitab, Excel
Responsibilities
Create and verify multiplex biomarker signatures for regulatory submission; Provide statistical input for clinical study designs and sample size estimates; Author statistical sections for protocols, analysis plans, and reports; Review and update SOPs and support audits; Provide expert input for analytical studies (reproducibility, precision, LOD, etc.)
Seniority
Senior, hands-on IC
