Experience

Smooth Drug Development, next generation e-CRO in Europe and Asia

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Data Analytics and SAS Programming Consultant

  • Feb 2022 - Present

  Training a group of biostatisticians, preparing presentations on data analysis and SAS programming, preparing documentation for program validation, writing SAS macros Training a group of biostatisticians, preparing presentations on data analysis and SAS programming, preparing documentation for program validation, writing SAS macros



PAREXEL

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Biostatistician

  • Oct 2018 - Oct 2021

  Participation in the following activities: 1. production of Statistical Analysis Plans and Table Listing Figure Shells 2. supporting the programming teams in production of analysis datasets, tables, figures and data listings 3. performing the review of the study results 4. communication with the Sponsors on statistical aspects of clinical trials, etc. Participation in the following activities: 1. production of Statistical Analysis Plans and Table Listing Figure Shells 2. supporting the programming teams in production of analysis datasets, tables, figures and data listings 3. performing the review of the study results 4. communication with the Sponsors on statistical aspects of clinical trials, etc.



Smooth Drug Development, CRO in Russia, CIS and Baltic States

• Biostatistician

  • Jul 2014 - Oct 2018

  Participation in the development of clinical trial documents: 1. implementation of the calculation of the sample size, 2. drawing up a plan for statistical data analysis, 3. creating a randomization plan, 4. implementation of statistical analysis of the received data, 5. interpretation of the data obtained during the clinical trial in terms of statistics, 6. drawing up a statistical report based on the results of the study, 7. participation in the formation of the final report on the clinical trial, etc. Show less