Senior/Staff Statistician, Assay Development

DELFI Diagnostics, Inc.•Palo Alto, CA

2d•$150,000 - $215,000

About The Position

DELFI Diagnostics is developing next-generation, blood-based cancer detection tests using advanced machine-learning methods and a platform called fragmentomics. The company's first product, FirstLook Lung, is a screening test for individuals eligible for lung cancer screening. DELFI Diagnostics is committed to serving humanity by leading with science, building with and for all, and prioritizing teamwork and empathy.

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
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.

Nice To Haves

Python proficiency
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.

Responsibilities

Design and execute analytical validation studies across the 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.
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.