Biostatistics

  • Statistical analysis of Bioequivalence studies
  • Sample size calculations
  • Statistical Analysis
  • Confidence Interval
  • Sample size calculation for all Phases I-IV
  • Statistical analysis plan
  • Analysis and Interpretation of all reports
  • Preparation and review of datasets
  • Quality requirements in statistics
  • Strong statistical skills; working knowledge of theories in mixed linear models, non linear model, survival analysis, censored data, method for rate and proportions, repeated measures, generalized estimating equations, equivalence testing, cross over design
  • Generate reports describing the sources of data, significant differences and relationships among these sources and the limitations on data reliability or usability.
  • Expertise in critical review of documents, guidance documents viz. clinical study reports, abstracts, posters, clinical trial synopsis, clinical trial registries, standard operating procedures, user manuals and forms