Universal Diagnostics S.A. · 2 months ago
Senior Biostatistician
United States
Full-time
Hybrid
Senior Level
7+ years expUniversal Diagnostics S.A. is an international company focused on early cancer detection through innovative diagnostic tests. They are seeking a Senior Biostatistician to contribute to the development and commercialization of Next Generation Sequencing (NGS) products, involving statistical analyses for colorectal cancer screening tests.
BiopharmaBiotechnologyMedical
Responsibilities
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
Qualification
Required
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
Benefits
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
Relocation support to the DFW area for on-site roles.
And more to come
Company
Universal Diagnostics S.A.
Universal Diagnostics S.A.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$133.51MKey Investors
European Investment BankQuest Diagnostics
2025-02-27Debt Financing· $20.96M
2024-08-19Series B
2023-11-20Series B· $70.22M
Leadership Team
Juan Martinez Barea
Executive President, Founder & CEO
Recent News
Google Patent
2025-05-04
2025-04-02
2025-02-08
Company data provided by crunchbase