I have started to work as a contract Biostatistician since 2013. For several years I have been continuously helping CROs and Pharma companies in Russia, as well as small-sized clients abroad. My expertise covers the following areas of study planning and conduct:

  • Sample size calculation for various study design
  • Randomization plans
  • Writing of statistical part of the Study Protocol
  • Creation of SAP
  • TFL shells design
  • Selection of applicable statistical methods
  • Full efficacy and safety analysis
  • Following local and international guidelines from ICH, EMA and FDA.