Delfi Diagnostics

General

• 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

Senior/Staff Statistician, Assay Development

Director

• Leadership across DELFI's clinical study portfolio, working with senior leadership and cross-functional teams including R&D, medical, quality, and regulatory.
• Develop and execute clinical studies that generate robust evidence for DELFI's products, including establishing clinical validity and utility.
• Advance DELFI's development of diagnostic products for cancer.
• Implement the five-year clinical development strategy based on clinical science and unmet needs in cancer diagnostics.
• Partner with R&D Biostatistics for clinical studies and analyze in accordance with protocols.
• Manage clinical development & operations groups and associated CROs and investigators.
• Develop and manage clinical trial timelines, budgets, and risks in accordance with product development processes.

Senior/Staff Statistician, Assay Development

Senior Director, Clinical Development