Senior/Staff Statistician, Assay Development

Delfi Diagnostics

Senior Statistician designing and executing validation studies for cancer detection assays. Collaborating across teams on statistical methods for innovative blood-based tests.

Posted 6/24/2026full-timePalo Alto • California • 🇺🇸 United StatesSenior💰 $150,000 - $215,000 per yearWebsite

Tech Stack

Tools & technologies

Python

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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

Benefits

Comp & perks

flexible time-off policy
401(k) retirement plan
extremely competitive medical, dental, and vision coverage
onsite lunch 3 days a week
other wellness related offerings

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

statistical methodsanalytical validationsample size calculationsstatistical analysis plansregulatory submissionsassay performanceRPython

Soft Skills

strong written communicationstrong verbal communicationcritical thinkingability to manage multiple prioritiescollaborative working stylementoring

Certifications

Doctoral degree in StatisticsDoctoral degree in BiostatisticsMaster's degree in related field