Senior/Staff Statistician, Assay Development

Job Description

Job 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.

DELFI has 1-2 designated in-office working days each week for employees who live within within 50 miles of Palo Alto, CA 

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.

• 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.

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.

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.