Senior Biostatistician

Today, precision medicine coupled with advanced diagnostics is taking over. However, those innovations in medicine come with an ever-increasing price tag driven by more expensive and complicated solutions, making them less accessible unless we do something about it.

Signatur Biosciences was established with the mission of making cutting-edge diagnostic tools accessible to more patients around the world. As a startup we have developed a technology to profile complex molecular signatures in a single reaction using qPCR machines already in place in every biomedical lab around the world. We are a spin-out of Imperial College London, backed by Y Combinator, with our head office in London and our laboratory in Liège, Belgium.

We take a data-driven approach to how we work — using data and evidence as a default part of every decision, not an afterthought. The rigour of the statistics behind a diagnostic result is what makes it something a clinician can act on and a patient can rely on.

This role can be based in either of our two countries:
the United Kingdom — hybrid from our London office or fully remote within the UK — or Belgium
, hybrid from our laboratory in Liège or fully remote within Belgium. You will be employed by our UK company or our Belgian company according to where you are based, on that country's standard terms.

We are seeking an exceptional, ambitious Senior Biostatistician to join us at Sig Bio.
You will be our first statistical hire — and you will own the discipline.

Reporting to our Chief Scientific Officer and working closely with our Chief Medical Officer, you will cover both the clinical and the analytical statistics behind our product development and our regulatory submissions. Our lead product is a qPCR-based prognostic test for breast cancer, heading into clinical validation, so the work in front of you is the work that decides whether the test is approvable: the endpoints, the sample size, the acceptance criteria, and the statistical rationale that has to stand up in a technical file and be defended in front of a notified body.

We are a team of sixteen, across London and Liège. There is no statistics function to join — there is one to build. If you have been the statistician who writes the plan and then watches someone else decide, this is the opposite of that. We are looking for someone who wants genuine ownership of a discipline in a small, fast-moving team, and who wants to help embed a genuinely data-driven, AI-native way of working across the business.

• Work with the clinical and medical team to define and optimise clinical study endpoints.
• Own sample size and statistical power estimation for clinical studies.
• Develop Statistical Analysis Plans.
• Analyse clinical study data and produce the corresponding statistical reports.
• Lead the statistical design, analysis and reporting for our analytical performance studies, in line with the relevant CLSI guidelines.
• Set and justify statistical acceptance criteria, and define the statistical basis for our quality control methods.
• Own the statistical methodology behind our algorithm, including its validation strategy.
• Produce statistical documentation to the standard required by our ISO 13485 quality management system.
• Communicate findings clearly to non-technical stakeholders, including leadership.
• MSc or PhD in statistics, biostatistics, or a closely related quantitative discipline.
• Substantial experience as a statistician in the in vitro diagnostics or medical device sector.
• Experience in clinical statistics: working with clinical and medical teams to optimise endpoints, sample size and power estimation, developing Statistical Analysis Plans, clinical study data analyses, and multivariate…