ABOUT THE COMPANY

Own the statistical strategy behind our clinical evidence — designing efficient studies, extracting publishable insights, and translating data into decisions that convince clinicians and regulators (FDA/CE).

ABOUT THE ROLE

Support ongoing clinical trials and regulatory interactions (FDA/Notified Bodies).

RESPONSIBILITIES

• Mass validation planning and analysis for pre-clinical and multi-center campaigns
• Design new clinical studies: protocols, SAPs, CRFs, endpoint definitions
• Optimize trial efficiency: reduce patient burden while preserving statistical significance
• Create publishable outputs: figures, tables, narratives for manuscripts and posters
• Contribute to cross-functional teams (R&D, QA/RA, Medical, Product)

QUALIFICATIONS

• MSc/PhD in Biostatistics, Statistics, Data Science, or Epidemiology
• 3+ years applying statistics to clinical, biomedical, or medical-device contexts
• Fluency in R or Python (SAS also acceptable)
• Experience producing SAPs, CSR inputs, and publication-ready outputs
• Excellent written communication in English

REQUIRED SKILLS

• Multi-center clinical studies / pre-clinical validation programs
• Regulatory submission experience (FDA Q-Sub, CE technical documentation)
• Simulation experience (bootstrap, Monte Carlo)
• ICH E6, ICH E9, ISO 14155 familiarity
• Git, Quarto/RMarkdown/Jupyter, basic SQL

PREFERRED SKILLS

• Audit-ready analysis pipeline with reproducible code and version control
• SAPs drafted/refreshed for key studies
• Clear plan for mass validation / multi-center evidence generation
• At least one publication-ready analysis package delivered