Lead Biostatistician
Core
Lead Biostatistician providing statistical support for clinical study design, analysis, and regulatory reporting for IVD molecular assays in oncology, infectious disease, and blood diagnostics.
Role type
Senior IC biostatistician (regulatory focus)
Builds
Statistical analysis plans, clinical study reports, and regulatory submissions for IVD products
Domain
Life sciences / In vitro diagnostics (IVD) / Oncology / Infectious disease
Required skills
Biostatistics, Clinical study design, Regulatory guidelines (FDA/CE-IVDR), Statistical modeling, SAS, R/Python, Mentorship
Preferred skills
IVD regulatory submissions, FDA CDRH interactions, CLSI standards
Technologies
SAS, R, Python, Minitab, Excel
Responsibilities
Provide end-to-end statistical analysis for IVD product life cycle; Author statistical sections for protocols and reports; Review SOPs and provide training; Support audits and analytical studies (LOD, precision, linearity)
Seniority
Senior, hands-on IC with mentorship