Data Analyst

We are sourcing for a medical device company seeking an experienced Data Analyst / Statistician for a focused validation project. The work involves complex statistical analysis of test data to support regulatory submission to the FDA. The project is fully remote, EU-based candidates welcome. Scope & Engagement Total estimated effort: ~250 hours, flexible scheduling Preferred capacity: ~50% Start date: July–August 2026 (flexible) Location: Remote, anywhere within the EU What You'll Be Working On - Conducting comparative and descriptive statistical analyses for test data validation per TIR101 standard - Statistically evaluating and justifying sample size reductions - Performing variant and article code comparisons across different environmental parameters - Preparing and documenting statistical results for FDA regulatory submission (510(k) process) Must-Haves - Degree in Statistics, Mathematics, Data Science, Biostatistics, or a related field - 5+ years of experience as a Statistician or Data Scientist - Solid hands-on experience with comparative and descriptive statistical methods - Experience in a regulated environment (medical devices, pharma, or biotech) - Familiarity with FDA submission processes or TIR101 standard (strong advantage) - Structured, independent working style Nice to Have - Direct experience with 510(k) submissions - Prior work in MedTech validation projects