Biostatistics

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

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