Biostatistics · Clinical Trials · Oncology & Hematology · AI/ML

BioSpark

Clinical Intelligence. Regulatory Precision.

Bridging clinical trials and artificial intelligence.

The gap no one is talking about

Everyone is hiring data scientists and engineers to build healthcare AI. Almost no one is asking the people who actually understand clinical trials — the workflows, the regulatory logic, the edge cases, the conversations with health authorities.

I spent 13 years in drug development, from academic research at Gustave Roussy to global programs at Novartis and Johnson & Johnson — CAR-T therapies, bispecific antibodies, pivotal Phase III trials. I've seen what happens when AI meets clinical development with deep domain expertise, and what happens without it. The difference is not subtle. It is the difference between a product that passes regulatory scrutiny and one that doesn't.

Clinical AI needs clinical trialists — not as validators at the end, but as architects from the start.

Two worlds. One bridge.

There are people who speak fluently about biostatistics, trial design, and regulatory submissions — but have never written a line of Python. There are people who build sophisticated ML pipelines — but have never read a protocol or an FDA guidance document.

BioSpark sits at the intersection.

If you're a biotech, a pharma company, or a healthcare SME looking for someone who speaks biostatistics and regulatory submissions as fluently as Python, machine learning, and cloud infrastructure — let's talk.