DELFI Diagnostics, Inc.
Diagnostics
Senior/StaffStatistician,AssayDevelopment
“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
Applying for this Senior/Staff Statistician, Assay Development role?
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