Senior/Staff Statistician, Assay Development

Responsibilities

• Design and execute analytical validation studies across our assay development pipeline, partnering with lab, software, regulatory, and data science teams
• Apply and develop statistical methods suited to NGS-based assays and liquid biopsy platforms
• Define and apply rigorous, pre-specified acceptance criteria and sample size calculations for assay performance
• Author statistical analysis plans, study reports, and regulatory submissions for both LDT and IVD pathways, and serve as an internal statistical consultant across functions
• Familiarity with IVD regulatory requirements and analytical validation standards (e.g., CLSI guidelines, FDA 21 CFR Part 820, ISO 13485, IVDR)
• Provide statistical leadership on complex or novel analytical validation problems, set standards for how AV studies are designed and analyzed at DELFI, and mentor junior team members

Requirements

• Doctoral degree in Statistics, Biostatistics, or a related field with 2+ years of industry experience; or Master's with 5+ years of industry experience
• Experience designing and analyzing applied statistical studies in analytical validation
• Proficiency in R, Python is a plus
• Strong written and verbal communication, including translating statistical reasoning for non-statistical audiences
• Strong critical thinking, ability to manage multiple priorities independently, and a collaborative working style
• Assay validation experience in a regulated environment (LDT or IVD), and familiarity with relevant CLSI guidelines