The Opportunity

Reporting to the Director of Assay Developmentthis role will be instrumental in the planning and execution of statistical analyses for both development and analytical validation studies on Universal DX's screening test for colorectal cancer.
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".

Why Now?

This is an exciting time to be at Universal DX. We are growing rapidly and scaling 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.

How you'll contribute

Study Design & Statistical Planning

• Develop and implement statistical analysis plans (SAPs) for assay development and validation studies
• Collaborate with cross-functional teams to design robust study protocols, including endpoint selection, sample size calculations, and study acceptance criteria.

Statistical Analysis & Interpretation

• Perform advanced statistical analyses, ensuring the accurate and timely delivery of results
• Provide data-driven insights to guide product development strategies.
Validation & Regulatory Support
• Lead statistical efforts for the design of analytical validation studies, including defining performance
metrics such as precision, accuracy, and sensitivity
• Contribute to regulatory submissions by preparing statistical reports, data summaries, and responses to
agency queries.

Cross-Functional Collaboration:

• Partner with internal teams, including Bioinformatics, Project Management, Quality Assurance, and Regulatory Affairs, to align activities with project milestones.
• Ensure alignment between statistical methodologies and regulatory/industry requirements (e.g., FDA, CLSI guidelines).
Documentation & Compliance
• Draft and review key technical documents, including SAPs, validation reports, and standard operating
procedures (SOPs)
• Maintain compliance with quality management systems (QMS) and relevant regulatory guidelines.
Leadership & Mentorship
• Provide guidance and mentorship to junior biostatisticians
• Lead cross-functional meetings to present statistical findings and methodologies.

Qualifications:

Required

‍
• Master's or Ph.D. in Biostatistics, Statistics, or a related field
• At least 5 years of experience in biostatistics, with a focus on analytical development and validation studies. Prior experience with designing development and analytical validation studies for NGS-based assays is strongly preferred
• Proficiency in statistical programming methods/tools (e.g., SAS, R, Python)
• Strong understanding of regulatory guidelines for diagnostic product development (e.g., FDA, CLSI)
• Excellent collaborative skills and a strong willingness to be part of a dynamic team
• Experience contributing to regulatory submissions, including 510(k)s or PMAs
• Comfortable working in fast-paced environment with ability to adapt to shifting priorities.

Preferred

• Expertise in oncology, biomarkers, or diagnostic product development
• Familiarity with Bayesian statistics, machine learning, or high-dimensional data analysis.

‍

Apply now