Biostatistician I

Role: Biostatistician I supporting development and validation of cancer diagnostic devices, focusing on NGS-based assays. Responsibilities: design and execute analytical and clinical validation studies; develop statistical models; collaborate cross-functionally on study design, data analysis, and regulatory documentation; contribute to regulatory submissions and respond to review queries; ensure statistical quality and accuracy of deliverables. Requirements: Master’s in Statistics, Biostatistics, Computational Biology, or related field with 2+ years’ experience, or PhD in the same fields; proficiency in R and Python. Preferred: PhD, industry or FDA internship experience, knowledge of machine learning, deep learning, NGS, cancer genomics, and medical device validation. High-Value: cancer diagnostics, NGS, analytical validation, regulatory submissions, collaboration with external partners. WorkSetup: unspecified; no travel indicated.