Senior Biostatistician

Signatur Biosciences; Greater London; Hybrid; GBP 90,000 - 120,000; Full time

Benefits offered by this job

Equity in the company

Flexible location UK/Belgium

Annual leave UK/Belgium

Job summary

Signatur Biosciences is hiring a Senior Biostatistician. You will be the first statistical hire, owning the discipline and collaborating with clinical, medical, and regulatory teams on product development and submissions.

You will shape endpoints, sample sizes, and validation strategies for a qPCR prognostic test, ensuring rigor for regulatory files and technical documentation.

Qualifications

• MSc or PhD in statistics, biostatistics, or related quantitative discipline.
• Substantial experience as a statistician in in vitro diagnostics or medical devices.
• Experience in clinical statistics with endpoint, sample size, and power estimation.
• Experience with CLSI guidelines and defending studies; ISO 13485 knowledge.
• Proficiency in R, or another validated statistical environment, with written outputs.

Responsibilities

• Define and optimise clinical study endpoints with the team.
• Own sample size and statistical power estimation for clinical studies.
• Develop Statistical Analysis Plans and analyses reports.
• Lead statistical design, analysis and reporting for analytical studies.
• Set acceptance criteria and statistical basis for quality control methods.
• Own the statistical methodology behind the algorithm and its validation.
• Produce statistics documentation for ISO 13485 quality management.
• Communicate findings clearly to non-technical stakeholders.
• Collaborate daily with non-statisticians to embed evidence-driven work.

Skills

R programming

Python

Data analysis

Statistical planning

Clinical statistics

Education

MSc or PhD in statistics

Tools

R

Python

Job description

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.

Location

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.

About the role

We are seeking an exceptional, ambitious Senior Biostatistician to join us at SigBio. 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.

Main Responsibilities

• 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 analyses.
• Experience in analytical statistics: precision, linearity, detection capability, interference, method comparison, stability and cut-off determination.
• Knowledge of the CLSI guidelines, and the ability to design and defend studies against them.
• Knowledge of ISO 13485, with practical experience producing statistical documentation inside a quality management system.
• Proficiency in R, or another validated statistical environment.
• A track record of turning statistical work into clear, actionable recommendations for colleagues who are not statisticians.
• Experience with IVDR performance evaluation and ISO 20916 clinical performance studies.
• Experience developing and validating clinical prediction models.
• Working knowledge of Python, and of version-controlled analysis workflows.
• Previous experience in an early-stage startup.
• Ownership. You are comfortable being the person accountable for a statistical position, not just the person who computed it.
• Rigour under time pressure. You know the difference between a defensible shortcut and an indefensible one, and you say which is which.
• Precision in writing. Most of what you produce is read by regulators, auditors and clinicians. It has to be unambiguous on paper.
• Judgement, not just method. Endpoint choice, power assumptions and cut-off justification are judgement calls that end up in the technical file. You are willing to make them and to be challenged on them.
• Collaboration. You will work daily with people who are not statisticians and you will make them better at using evidence.

What we offer

• Competitive salary, based on experience.
• Equity in the company.
• Flexible location across the UK and Belgium, as set out above.
• Annual leave: in the UK, 21 days plus bank and public holidays. In Belgium, statutory annual leave plus 12 RTT days.
• Candidates who need UK work authorisation are considered on a case-by-case basis.

Signatur Biosciences is an equal-opportunity employer promoting diversity and inclusion in the workplace. We welcome applications from all qualified candidates regardless of age, disability, gender identity, marital or civil partnership status, pregnancy or maternity, race, religion or belief, sex or sexual orientation.