Senior/Staff Statistician, Assay Development
Posted about 2 months ago
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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:
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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.
Other open roles at DELFI Diagnostics, Inc.(6)
DELFI Diagnostics uses the power of AI, machine learning and next-generation liquid biopsy to screen, detect and monitor cancer in a whole new way.
Key team members
Gordon Baldwin
Sumant Turlapati
Wouter Meuleman
Maricar Pacquing, DO
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