About the role We’re hiring an experienced statistician to play a key role in the analytical validation of our cancer detection assays, partnering across assay development, lab operations, software, regulatory, and data science. The ideal candidate will provide statistical leadership on complex AV problems, set standards for how studies are designed and analyzed at DELFI, and mentor junior team members. What you’ll do 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. What you’ll bring Required 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. Preferred Experience with NGS‑based assays or liquid biopsy platforms. Experience with FDA pre‑submission meetings or direct agency interactions. Ability to develop novel statistical methods from first principles. Publications or presentations in diagnostic statistics, analytical validation or clinical validation. $150,000 – $215,000 a year. Actual base pay will consider experience, skillset, education, and geography. This role may be eligible for other forms of compensation, including an annual bonus and a new hire equity grant, subject to the terms of the applicable plans and Company discretion. All employees are also eligible for DELFI’s comprehensive and competitive benefits package, including but not limited to: a flexible time‑off policy; a 401(k) retirement plan; an extremely competitive medical, dental, and vision coverage; onsite lunch 3 days a week; and other wellness‑related offerings. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. #J-18808-Ljbffr