💼 About This Role

You'll scrutinise clinical evidence submitted by manufacturers of AI-enabled medical devices, evaluating study design and statistical methodology. You will collaborate with a multidisciplinary team to assess technical documentation and support market access. This is an opportunity to join a leading authority in AI medical device certification.

🎯 What You'll Do

• Contribute to clinical evaluation processes for innovative medical devices
• Collaborate with multidisciplinary team on technical documentation assessments
• Create content on biostatistics, clinical research methodology, and real-world evidence
• Represent Scarlet at events and conferences
• Screen and action regulatory insights from latest research and standards

📋 Requirements

• Degree in medical statistics, biostatistics, epidemiology, or similar
• Experience applying biostatistical methods in clinical research or critically appraising statistical methodologies
• Experience appraising or analysing real-world data and observational studies with bias frameworks
• Working understanding of AI/ML model development and validation in clinical contexts

✨ Nice to Have

• Knowledge of clinical evaluation standards and guidance (e.g., ISO 14155, MEDDEV 2-7/1 Rev.4)
• Experience designing or contributing to interventional and non-interventional clinical studies

🎁 Benefits & Perks

• 💰 Competitive salary
• 📈 Equity options

📨 Hiring Process

Estimated timeline: 2-3 weeks

1. 1Intro call with Sandy· 30 min
2. 2Interview with Yun· 30 min
3. 3Technical interview with Mihir· 1 hour
4. 4Culture and values interview with James and Jamie· 1 hour