The Opportunity:

Universal DX is seeking an experienced Senior Biostatistician to 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 development, verification, and validation studies on 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 cancer. As part of the team, you will be in a Company that aims 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, verification, and validation studies.

· Collaborate with cross-functional teams to design robust study protocols, including defining acceptance criteria, sample size calculations, and power analyses.

· 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 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:

· PhD or Master’s degree in 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.

· 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 such as R Markdown

· 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.