Statistics that start with the question, not the software.

The job of a study statistician is not to produce tables. It is to work out what the data shows, how strong that finding is, and how it connects to what the study set out to prove. Our biostatisticians support design, analysis and interpretation across clinical development, working with sponsor teams or as the statistical function for smaller companies that do not have one.

What we do

  • Study design and statistical consulting. Input on endpoints, methodology, sample size and analysis strategy at the stage where it is cheapest to get right.
  • Statistical analysis plans. Writing and reviewing SAPs that define populations, endpoints, estimands where relevant, methods and handling of missing data, consistent with the protocol and the study's objectives.
  • Randomisation schedules. Generating and reviewing schedules to the approved design, with attention to allocation integrity, reproducibility and documentation.
  • Analysis and interpretation. Endpoint and treatment-effect analysis, and an honest account of how robust the results are.
  • Protocol, CRF and reporting review. A statistician's read of protocols, CRFs, eCRFs and reporting specifications to catch inconsistent endpoint definitions or data collection gaps before they become analysis problems.
  • Interim analyses and DMC or DSMB support. Statistical deliverables for planned interim looks and monitoring committees, under the study's governance and confidentiality procedures.
  • Clinical study report support. Verification of results, consistency checks between outputs and report text, and support for statistical sections.
  • Integrated summaries. Statistical input to ISS and ISE for submissions.
  • Publications and ad hoc analyses. Additional analyses for manuscripts, presentations and emerging scientific questions.

Working with programming and data management

Because our statisticians sit with the programmers and data managers, an unclear endpoint definition gets sorted out in a conversation, not in a ticket. That is a quiet advantage, but it saves time on every study.

Tell us the stage your study is at and the decision it needs to support.