Senior Research Scientist - Clinical and Regulatory Expertise (contract)

We are now building the next generation of AI-powered, privacy-first, clinically backed digital health solutions. Scientific integrity is the foundation of our work, engaging over 100 thought leaders and establishing research partnerships with institutions like Stanford, Yale, John Hopkins and more.

The Role: Setting the gold standard for software as a medical device
We are seeking a highly skilled Senior Research Scientist to join our Science team for 20-30 hours per week. This role is centered on working with big data to answer research questions within Women’s Health to write a first-author paper for a top-tier journal. You will also be supporting the successful execution of our clinical investigation into the safety and effectiveness of our new medical device, and the scientific strategy and planning for future devices. The mission impossible of your job is to bridge the gap between "interesting research", "clinical proof", “regulatory requirements”, and “business metrics”. 

You will work closely with the Lead Research Scientist and the Director of Science, but your impact of research will be felt through the whole company, across the legal, compliance, and product teams.

What you'll be doing

You'll be responsible for:

• Provide day-to-day scientific input and oversight for ongoing clinical studies. This involves data analysis, manuscript writing, and ensuring protocol adherence across teams.
• Assemble high-quality regulatory documents (including study protocols, statistical analysis plans, study reports) for submission to the FDA and notified bodies (EU MDR).
• Prepare, extract, and analyze large-scale datasets, performing statistical analysis and developing reporting specifications (SAPs, sample size estimation).
• Write research papers for publication in peer-reviewed scientific journals.
• Directly contribute to Flo’s scientific strategy by designing and planning future medical device studies and advising on global regulatory compliance requirements for new products.

Must Have:

• PhD or Postdoc in Public Health, Reproductive Medicine, Population Health, Biostatistics, or other related fields.
• Direct experience of leading the design, execution, and data analysis of clinical research studies.
• Experience preparing documentation and supporting trials subject to FDA, EU MDR, or other global regulatory compliance bodies (Class II or higher). 
• Strong working experience with data analysis and statistics (e.g. survival/lifetable analysis, linear and logistic regression, mixed models, etc.) in Python or/and R, including strong proficiency in writing complex SQL-queries.
• Strong publication record in peer-reviewed journals (as a first-author) and proven ability to write rigorous study protocols, statistical analysis plans, and scientific reports.

Nice to Have:

• Working experience in projects related to Software as Medical Device (SaMD).
• Prior experience applying predictive models such as decision tree algorithms (e.g., CatBoost) or Bayesian networks.
• Experience of conducting systematic reviews and meta-analyses.
• You are meticulous but fast. We are a high-growth tech company. We need someone who can maintain academic-level precision at the speed of a scale-up.

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