Biostatistics

Professional statistical expertise is essential to underpin the scientific work carried out at NIBSC. Our group applies a wide range of statistical techniques to the variety of data from our scientific divisions. Applying statistical methods to biological assays that exhibit a greater variability than chemical-based tests is particularly important.

In the Biostatistics group we collaborate closely with the Vaccines, Biotherapeutics and Advanced Therapies divisions, and we are responsible for several activities.

These include the design, analysis and interpretation of international multi-centre collaborative studies to establish International Standards and other reference materials.

We provide statistical support for NIBSC control functions within the framework of the Institute quality system including:

• assay validation
• experimental design and analysis
• data monitoring
• review, development and validation of software for the analysis of batch-release assays

We support the Institute’s research and development programme through statistical consultancy and analysis, and develop software and statistical applications in the context of NIBSC’s work.

Advancing the refinement, reduction and replacement of animal experiments (the 3Rs) is another key area. We do this through advising on how to improve assay design and analysis to optimise the use of animals, the NIBSC Animal Welfare and Ethics Review Body (AWERB), includes a statistician committee member from our group.

Our group collaborates with different external organisations and working groups including the World Health Organisation (WHO) and the European Directorate for the Quality of Medicines & Healthcare (EDQM).

Finally, we provide training in applying statistical methods and use of software, both internally and externally.