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
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