Senior/Staff Statistician, Assay Development

DELFI Diagnostics•Palo Alto, CA

1d•Onsite

About The Position

DELFI Diagnostics is seeking an experienced statistician to play a key role in the analytical validation of their cancer detection assays. This role involves partnering across assay development, lab operations, software, regulatory, and data science. The ideal candidate will provide statistical leadership on complex analytical validation (AV) problems, set standards for how studies are designed and analyzed at DELFI, and mentor junior team members. DELFI Diagnostics is developing next-generation, blood-based tests using advanced machine-learning methods to whole-genome sequencing data on their DELFI platform, which relies on fragmentomics to detect cancer. Their first product, FirstLook Lung, is a laboratory-developed screening test for individuals eligible for lung cancer screening.

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 is a plus
Familiarity with IVD regulatory requirements and analytical validation standards (e.g., CLSI guidelines, FDA 21 CFR Part 820, ISO 13485, IVDR).
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 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.
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.