3d
Sr. Biostatistician
Sr. Biostatistician
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About our Company:
Universal DX, Inc. is an international Company with a highly experienced team focused on cracking cancer's code. Through our multi-omics and bioinformatics models, we have figured out how to read the disease's signals in blood with high accuracy to detect cancer in its earliest stages. Starting with a colorectal cancer screening liquid biopsy test, we are building a multi-cancer platform that can identify the unique DNA regions associated with different types of cancers.
The Opportunity:
Universal DX is seeking an experiencedSenior Biostatisticianto join our growing product development team working on the development and commercialization of Next Generation Sequencing (NGS) products for early cancer detection. This role will be instrumental in the planning, development, and execution of statistical analyses for Analytical Validation (AV) studies supporting Signal-C, Universal DX's screening test for colorectal cancer. This role will work flexibly within a matrixed organization, collaborating across multiple teams within Product Development.
You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancers.Aspart of the team, you will be in a Company that aims more thanto becomeone of the leaders in the industry. We want to have a huge positive impact on society by achieving the ambitious purpose of "making cancer a curable disease by detecting it earlier".
How you'll contribute:
•Develop and implement statistical analysis plans for IVD development, verificationandAnalytical Validation (AV)studies.
•Collaborate with cross-functional teams to design robust study protocols, including defining acceptance criteria, sample size calculations, power analyses,and handling of exclusions/deviations.
•Perform advanced statistical analyses, ensuring accurate and timely delivery of results.
•Develop, validate, and maintain traceable analytical workflows for statistical reporting, ensuring reproducibility and compliance with regulatory requirements.
•Build and manage automated, version-controlled reporting pipelines using tools such as R Markdown/PythonJupyterNotebooks,and Git, with clear documentation to support audit readiness and regulatory submissions.
•Contribute to regulatory submissions by preparing reports, data summaries, and responses to agency queries.
•Provide technical guidance and mentorship to other team members.
•Lead and contribute to cross-functional meetings, presenting data-driven insights to guide product development strategies.
What you'll bring:
•PhDin Biostatistics, Statistics, or related field, or equivalent professional experience demonstrating comparable expertise.
•7+ years of experience in biostatistics, with a focus on analytical development and validation studies for IVD devices.
•Demonstrated experience drafting Statistical Analysis Plans (SAPs) for regulated studies (development/AV/V&V), including alignment to protocol objectives, endpoints, and acceptance criteria.
•Proven ability to develop validated scripts and maintain traceable, reproducible analytical workflows
•Experienced in managing version-controlled statistical codebases (Git), including proper documentation and traceability for regulated submissions
•Demonstrated experience building and maintaining automated reporting pipelines using tools suchas RMarkdown and/or PythonJupyterNotebooks.
•Strong understanding of regulatory guidelines for diagnostic product development (e.g., FDA, CLSI)
•Experience contributing to regulatory submissions, including 510(k)s or PMAs.
•Excellent collaborative skills and a strong willingness to be part of a dynamic team.
•Comfortable working in a fast-paced environment with the ability to adapt to shifting priorities.
•Preferred: Familiarity with machine learning or high-dimensional data analysis.
What we´ll offer:
•22 days of PTO with the possibility to carry over 10 days to the following year.
•Company Holidays, plus your Birthday off!
•Company-sponsored benefit plans, including medical, dental, and vision insurance plus life, STD, and LTD coverage, and 401(k).
•Flexible work schedule
•And more to come!
Why Now?
This is an exciting time to be at Universal DX. We are growing rapidly and starting our US operations by building up our team, starting our lab and business operations, and establishing strategic partnerships.
We are looking for passionate changemakers to be a part of our journey in this expansive time for us.
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