Biostatistics

The biostatistics team is dedicated to robust clinical research and understands the relevance of statistics during all stages of a study, from planning to data collection and reporting phases of a study. The statisticians are able to engage in medicinal discussion with all relevant stakeholders and provide support for peer-reviewed publications. This ensures that all results are leveraged to their fullest potential.

Services refer to:

  • Study design
  • Review of study protocols
  • Planning and performing statistical analyses
  • Statistical sections of study reports and publications
  • Consulting during filing and approval processes
  • Consulting for publication strategies
  • Participation at iDMCs
  • Coordination of data acting as iDCC

Special aspects of clinical trial design and data analyses include:

  • Selection of study variables and control groups adequate for the study objective
  • Techniques to avoid bias
  • Randomization plan (e.g. using permuted-blocks or adaptive methods)
  • Specification of the statistical hypotheses for superiority, non- inferiority or equivalence studies
  • Selection of appropriate statistical tests and models
  • Integration of interim analyses for safety, superiority or futility   
  • Multiple comparison techniques
  • Methods allowing adjustment for confounding variables and identification of prognostic and predictive factors (e.g. analysis of covariates or logistic regression analysis and Cox proportional hazard methods)
  • Survival time analysis (e.g. Cox proportional hazard methods)
  • Interim analysis using alpha spending functions
  • Repeated measurement methods for longitudinal data
  • Closed testing procedures for multiple comparison
  • Mixed models to handle both fixed and random effects