This programme has been designed to support people who have had a career break or are trying to transfer their skills in to a new sector or one they used to work in. We know that any gap in work experience or a move away from a sector or skill set makes it very hard to return or join through standard recruitment channels.

As a candidate working with STEM Returners you have access to free CV writing and Interview coaching and if you are successful in securing the role you’ll get access to coaching and mentoring programme to help you thrive in the role.

If you meet the criteria for this role but are unsure if you are eligible for the programme, we encourage you to make an application.

About Faster Diagnostics Ltd

Faster Diagnostics Ltd (FDL) is an early-stage UK diagnostics company starting clinical trials for a blood plasma diagnostics triage test.

Purpose of the role

The postholder will provide the statistical expertise underpinning FDL’s clinical evidence programme for its blood plasma diagnostic test (IVD Class C). They will lead the design and sample size / power specification for analytical and clinical performance studies, ensuring each study is statistically robust and appropriately powered to support UKCA Class C IVD approval and FDA De Novo submission. FDL is specifically looking for statistical expertise grounded in diagnostics/medical device trials — rather than pharmaceutical drug trials — given the materially different design, endpoint, and regulatory considerations (e.g. diagnostic accuracy, sensitivity/specificity, and analytical performance, as opposed to safety/efficacy endpoints for a drug).
This is a specialist individual contributor role, initially structured as part-time and project-based to reflect the current stage of the FAST clinical programme, with the possibility of evolving into a more substantial part-time or full-time position as the programme progress. The postholder will work closely with the CEO, the Principal Investigator, the Medical Director, and may liaise directly with the CRO’s clinical trials function.

Key responsibilities:

1. Study Design & Sample Size Specification

• Lead statistical design of analytical and clinical performance studies for the plasma-based diagnostic test, including sample size and power calculations for sensitivity, specificity, and other diagnostic accuracy endpoints.
• Define primary and secondary endpoints, acceptance criteria, and statistical hypotheses in collaboration with the Principal Investigator and Medical Director.
• Specify inclusion/exclusion criteria and stratification approaches to ensure representative, statistically valid patient cohorts.
• Advise on study design methodology appropriate to IVD Class C performance evaluation requirements (e.g. diagnostic accuracy, precision/reproducibility, and reference interval studies).
• Contribute statistical input to protocol development, ensuring designs are fit for UKCA and FDA regulatory scrutiny.

2.  Statistical Analysis & Reporting

• Develop and maintain Statistical Analysis Plans (SAPs) for each study within the FAST clinical programme.
• Perform or oversee statistical analyses of clinical and analytical performance data, including ROC/AUC analysis, confidence intervals, and non-inferiority or equivalence testing as applicable.
• Author the statistical sections of clinical research reports to be published (3+), performance evaluation reports, and regulatory submission documents.
• Support interim analyses and data review meetings; advise on any adaptive design elements.
• Liaise with the CRO’s clinical trials function to ensure consistency and quality of statistical outputs.

3. Regulatory & Data Standards

• Ensure statistical methodology aligns with, or is equivalent to, relevant CLSI diagnostic performance guidelines, and STARD reporting standards.
• Contribute statistical evidence summaries for the UKCA Class C technical file, FDA De Novo submission, and NICE health technology assessment preparation.
• Maintain audit-ready statistical documentation in line with FDL’s document control standards.

Requirements:

• Experience as a Biostatistician / Clinical Trial Statistician in the UK commercial or CRO sector, specialising in diagnostics trials (IVDs / medical devices)
• Postgraduate qualification (MSc or PhD) in medical statistics, biostatistics, or a closely related quantitative discipline.
• Hands-on experience designing and specifying sample sizes for clinical trials or diagnostic performance studies, including power calculations for sensitivity, specificity, and other diagnostic accuracy metrics.
• Experience authoring Statistical Analysis Plans (SAPs) and the statistical sections of clinical study reports or performance evaluation reports.
• Ability to communicate complex statistical concepts clearly to non-statistical stakeholders — clinicians, regulators, and investors.
• Demonstrable ability to work autonomously and manage a varied workload within a part-time or project-based arrangement.

Working at Faster Diagnostics Ltd:

Flexible working – FDL is committed to genuine flexible working. This role has been structured as part-time and project-based from the outset — not as a reduced version of a full-time position — to match the current phase of the clinical programme. The postholder will agree working patterns and scope with the CEO at the point of appointment, and any future move towards a more full-time role will be discussed and agreed jointly as the programme develops. These arrangements will be recorded in the individual’s contract or services agreement.

Location:

• Remote (UK). Occasional, planned travel to NPL Teddington, and London