Biostatistician - Device (clinical)

Clinical Biostatistician — Medical Diagnostics (EU MDR / FDA)
On-site: Porto, Portugal

Regulatory Scope: EU MDR, FDA, ISO 14155

A hands-on biostatistics role in a diagnostics scale-up entering EU MDR and FDA clinical validation. You will develop SAPs, sample size calculations, and regulatory-grade data structures, translating validated R&D into robust clinical evidence alongside clinical and regulatory teams.

What You Will Do

• Define the statistical strategy for clinical investigations

• Lead sample size calculations, SAP development, and TFL structures

• Translate R&D outputs into regulatory-grade clinical data for EU MDR and FDA

• Partner with clinical, data, and regulatory teams to design robust studies

• Act as the statistical authority for submissions and notified body interactions

• Ensure alignment to ISO 14155 clinical investigation standards

What We’re Looking For

• MSc or PhD in Biostatistics, Statistics, or related discipline

• 3+ years’ experience within medical device or pharma clinical studies

• Strong hands-on expertise in SAS, R, or Python

• MUST HAVE direct experience with EU MDR, FDA requirements, and ISO 14155

• Ability to communicate statistical rationale clearly to non-statistical stakeholders

• Comfortable operating in a fast-paced, high-visibility scale-up environment

Why This Role Is Different

Most biostatistics roles are several steps removed from patient impact.

In this position, your statistical work directly determines whether a life-saving diagnostic reaches patients worldwide.

Lewis Finch — lfinch@barringtonjames.com | +44 (0)1293 776644