Clinical Evidence Specialist at Scarlet

You will serve as the biostatistics anchor for a multidisciplinary team certifying the world’s most innovative AI medical devices. By scrutinizing clinical evidence, study designs, and real-world data, you will directly determine which bleeding-edge healthcare technologies are safe enough to reach patients, ensuring rigorous validation standards in a rapidly evolving field.

• Conduct deep-dive assessments of clinical evidence packages for AI/ML devices, evaluating statistical methodology, sample sizes, and bias frameworks like ROBINS-I.
• Collaborate with clinicians and AI researchers to validate model performance against challenges like dataset shift and performance generalization using TRIPOD-AI and DECIDE-AI.
• Educate internal teams and external stakeholders on biostatistics and real-world evidence to improve the overall quality of medical device submissions.

• Holds a degree in biostatistics, epidemiology, or medical statistics with deep expertise in critical appraisal of clinical studies and scientific literature.
• Demonstrates a robust understanding of how AI/ML models are clinically validated, specifically identifying risks like algorithmic bias and dataset shift.
• Possesses practical experience in monitoring clinical investigations or assessing real-world data within a regulatory or research environment (e.g., ISO 14155 knowledge).

• Work at Europe's only Notified Body specializing in AI, placing you at the absolute forefront of how the world regulates and adopts medical machine learning.
• Join a high-growth, Creandum-backed team of 65 people with exponentially growing revenue and a mission to accelerate universal access to advanced healthcare.
• Directly influence the industry by defining evidence standards for AI in medicine and representing the firm at major global conferences and regulatory events.