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.