Vice President, Measurement Science & Statistics

Posted 17 Days Ago
Be an Early Applicant
Palo Alto, CA
Hybrid
300K-380K Annually
Senior level
Artificial Intelligence • Healthtech • Biotech
The Role
The VP of Measurement Science and Statistics will lead an interdisciplinary team in developing statistical analysis plans for validation of diagnostic products, ensuring performance, and maintaining quality in compliance with regulatory standards. Responsibilities include managing projects in statistical process control, collaborating with various teams, and communicating findings to internal and external stakeholders.
Summary Generated by Built In

About Us


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.


The VP, Measurement Science and Statistics is a seasoned R&D leader who is responsible for working at the interface of statistics, lab operations, and molecular diagnostics and managing an interdisciplinary team of scientists and statisticians. This role will collaborate with teams in data science/machine learning, assay development, software & data management, and clinical development to ensure that DELFI’s diagnostic test performance at scale meets requirements. Reporting to the CTO, you will work closely with medical and laboratory leadership, and present findings to internal teams and external partners. This position requires expertise in molecular diagnostics assays, statistical process control, team leadership, and strong communication skills. This role is an excellent fit for those who are decisive, proactive and bring a balance of high IQ and EQ.

What You'll Do

  • Lead the development of fit-for-purpose statistical analysis plans for analytical & clinical validation of products in development
  • Manage and lead a team of assay & clinical statisticians and data scientists working at the interface of assay, data science, and lab operations
  • Collaborate with peers leading software, assay design & development, comp bio / ML, laboratory operations, and clinical development to substantively advance DELFIs R&D objectives
  • Partner closely with lab director and quality & regulatory staff to develop, implement, and monitor quality control and quality assurance methods to ensure performance of diagnostic product(s) on market
  • Uphold clinical trial integrity and timelines in conjunction with clinical development team
  • Present work in internal and external partner & regulatory meetings both nationally and internationally

What you’ll bring to DELFI (Required)

  • PhD in any quantitative science (Biochemistry, Computational Biology/Bioinformatics, Biostatistics, Mathematics, or equivalent)
  • 8-10 years’ industry experience in applying advanced industrial statistics concepts (measurement systems analysis, design of experiments, statistical process control) to real-world assays and data 
  • Thorough grounding in the development of assay performance metrics, measurement and testing methods, and predictive modeling and simulation tools
  • 2-3 years’ experience supervising analytical and/or clinical validation studies for medical device / in vitro diagnostics development under formal design controls
  • Experience working with clinical data, i.e. collection, cleaning, and management of subject data in compliance with regulatory standards
  • At least 5 years’ experience designing/developing or optimizing high throughput sequencing technologies and/or molecular diagnostic assays
  • Experience working in a regulated setting including CAP/CLIA or FDA IVD, and with guidelines such as Clinical Laboratory Standards Institute (CLSI), Good Clinical Practice (GCP), etc.
  • 10+ years of experience leading and managing teams exemplifying best practice in recruiting, team-building, employee performance management and career development, goal-setting, and cross-functional collaboration 
  • Superb written, verbal communication, and influencing and presentation skills, including the ability to communicate complex concepts succinctly to a variety of audiences

What we offer full-time employees

  • 100% paid medical, dental and vision premiums for employees and dependents
  • 4 months fully paid parental leave
  • Flexible Time Off
  • 5 day winter break in December
  • A meaningful mission and strong company culture

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.


This position is not eligible for agency partnership. Resumes and outreach from staffing representatives will be declined.


Top Skills

Machine Learning
The Company
HQ: Baltimore, MD
137 Employees
On-site Workplace
Year Founded: 2019

What We Do

DELFI uses artificial intelligence and whole genome sequencing to sensitively detect unique patterns of DNA fragmentation in the blood of patients with cancer.

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