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Staff Statistician, Assay Development

Organization

Delfi Diagnostics

Job Location

1810 Embarcadero Road
Palo Alto, CA 94303
United States

Job Description

The lead statistician works closely with members of cross-functional teams (biologists, engineers, data scientists, and so on) and collaborates in the development and validation of cancer detection and monitoring products, designing and implementing statistical analyses and studies. Experience working in a highly regulated environment is highly preferred. 

 

What you’ll do:

    • Design and execute verification or validation studies with significant autonomy, both for obtaining CLIA certification, CAP accreditation and for submission to the FDA or for IVD regulations.
    • Provide technical guidance and leadership in planning studies, experiments, and analyses (including but not limited to LoB, LoD, LoQ, R&R and precision, linearity, accuracy, and other studies)
    • Represent data science and biostatistics and communicate efficiently and effectively in cross-functional teams, including interfacing with external regulatory agencies, as applicable
    • Act as an internal statistical consultant to other functional groups or their members by providing expert advice on statistical methodology, and assist with the training of biostatistics team members
    • When challenges arise in interdisciplinary project teams, identify and communicate risks or concerns, and present potential solutions
    • Author and revise statistical analysis plans, reports, and controlled documents
    • Take full ownership of work tasks and assigned projects, and complete work within timelines
    • Lead or support cross-functional teams

Requirements

Required:

    • PhD degree in Statistics, Biostatistics, or in a related field and three plus (3+) years of relevant work experience; or Master’s Degree in Statistics, Biostatistics, or in a related field and six plus (6+) years of relevant work experience; or a Bachelor’s Degree in Statistics, Biostatistics, or in a related field and eight plus years ( 8+) years of relevant work experience.
    • Four (4) years or more of practical experience designing and implementing statistical analyses in an applied statistics field
    • Four (4) years or more of experience with statistical software such as R, SAS, JMP, or Python
    • Desire to learn about cancer genetics and detection and contribute to a collaborative and mutually respectful working environment
    • Expert knowledge of statistics and advanced methods in diagnostic medicine, including the ability to produce novel methods based on first principles understanding
    • Strong critical thinking skills, including a logical approach to decision making and study or analysis design
    • Previous experience in a regulated laboratory and product development environment
    • Ability to work independently while managing multiple objectives and timelines
    • Superior written and verbal communication and presentation skills

Preferred:

    • A background in molecular diagnostics is a plus
    • Familiarity with cancer genetics is a plus

About Our Organization

Our mission is to cure cancer through high performance, accessible early cancer detection.  That means saving lives. 

 

Delfi Diagnostics is a Johns Hopkins spinoff focused on the non-invasive detection of cancer at earlier stages, when it is most curable. DELFI uses artificial intelligence and whole genome sequencing to detect unique patterns of DNA fragmentation in the blood of patients with cancer. These analyses are performed through simultaneous examination of millions of DNA sequences using machine learning to identify tumor-specific abnormalities.

 

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.