DELFI Diagnostics, Inc.
Diagnostics
Senior/StaffStatistician,AssayDevelopment
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior/Staff Statistician, Assay Development at DELFI Diagnostics, Inc.. Skills: statistical leadership, analytical validation, assay development, statistical methods for NGS-based assays and liquid biopsy platforms. Design and execute analytical validation studies across our assay development pipeline. Apply and develop statistical methods suited to NGS-based assays and liquid biopsy platforms”
What You'll Achieve.
save lives on a global scale; disrupt the path of cancer for all
Industry & Context.
critical thinking; complex or novel analytical validation problems
What They're Looking For.
Must Have
Doctoral degree in Statistics, Biostatistics, or a related field with 2+ years of industry or Master's with 5+ years of industry experience, Experience designing and analyzing applied statistical studies in analytical validation, Proficiency in R, Assay validation experience in a regulated environment (LDT or IVD), Familiarity with relevant CLSI guidelines
Nice to Have
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
What You'll Do.
Design and execute analytical validation studies across our assay development pipeline
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
and regulatory submissions for both LDT and IVD pathways
Provide statistical leadership on complex or novel analytical validation problems
Set standards for how AV studies are designed and analyzed at DELFI
Mentor junior team members
How You'll Work.
Team & Collaboration
partnering across assay development, lab operations, software, regulatory, and data science; partnering with lab, software, regulatory, and data science teams; serve as an internal statistical consultant across functions; Build With & For All; teamwork
Communication Scope
written and verbal communication; translating statistical reasoning for non-statistical audiences
Process & Methodology
ability to manage multiple priorities independently
Full Job Description
## Description DELFI Diagnostics, Inc. (DELFI Diagnostics) is developing next-generation, blood-based tests that are reliable, accessible and deliver a new way to help detect cancer. Employing advanced machine-learning methods to whole-genome sequencing data, the DELFI ("DNA EvaLuation of Fragments for early Interception") platform is built to address the highest-burden health challenges. DELFI Diagnostics prioritizes solutions that have the potential to save lives on a global scale, including for historically underserved populations. DELFI Diagnostics’ platform relies on fragmentomics – the discovery that cancer cells are more chaotic than normal cells and, when they die, leave behind tell-tale patterns and characteristics of cell-free DNA (cfDNA) fragments. FirstLook Lung, for individuals eligible for lung cancer screening, is DELFI Diagnostics’ first laboratory-developed screening test and can be part of routine blood work. FirstLook Lung uses millions of data points to reliably identify individuals who may have cancer detected through low-dose CT, including early stage disease with a negative predictive value of 99.8 percent. This test has not been cleared or approved by the FDA. In our passionate pursuit to radically improve health outcomes, we serve humanity when we: Lead with Science, Anchor in Pragmatism: We pioneer life-changing science by ensuring quality, transparency, and rigor at all times. We explore thoughtfully, experiment smartly, and deliver impact with conviction. Build With & For All: We embrace diverse backgrounds to innovate and achieve together. We are not just building a product - we aim to disrupt the path of cancer for all - no matter geography or socioeconomic class Put We over I: We are a home for high-performing people. Through teamwork, we build collective intelligence. Each of us wins when those we serve and those who serve with us--win. We show up with empathy, humility, and integrity at every step of the journey. ## About the role W
Applying for this Senior/Staff Statistician, Assay Development role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Lever
- Lever uses a streamlined one-page form — apply in under 5 minutes.
- LinkedIn import works well; review parsed data before submitting.
- The cover letter field is optional but visible to reviewers — use it to differentiate.
- Referral codes from employees can significantly boost visibility of your application.
ANONYMOUS · UNFILTERED
What do employees actually say about DELFI Diagnostics, Inc.?
Real rants from real employees. Read before you apply.