Experience

GCE Solutions Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Sr. Statistician

  • 2016 - Present

  Providing expert statistical input into and review of clinical trial deliverable (Phase II-III-IV studies) for Client Novartis (i.e. analysis plans, table shells, programming and table specifications, data review, tables, listings, figures and statistical sections for integrated reports) and data management deliverables (i.e. database design, validation checks and critical data) and accompanying to FDA/EMA regulatory submission.



AstraZeneca

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr. Statistician

  • 2006 - 2015

  Providing professional statistical contributions to optimally design, analyze, report and interpret a series of clinical studies in Neuroscience and CV/GI area • Worked as statistician of clinical study in Neuroscience, CV/GI area and supported clinical studies project of Phase I-II-III-IV, including publications• Participated in cross-project activities: as statistician in Clinii (Clinical information infrastructure) project, as CISGO statistical network expert from Neuroscience in CISGO (Clinical Information Standards Governance Organization) project



Endo International plc

• Ireland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Statistical Analyst

  • Apr 2005 - Oct 2005

  • Designed clinical trials: providing hypotheses, sample size estimates, tables, listings and figure programs• Conducted Statistical Analyses • Did SAS programming to accomplish Statistical Analyses (experience with logistic regression, GEE, repeated measures, survival, COX models)• Performed validating output of SAS programs for efficacy and safety analyses• Reviewed protocols and provided enhancement of Statistical Analysis Plan



University of Delaware

• United States
• Higher Education
• 700 & Above Employee

• Research Assistant

  • Jan 2004 - Dec 2004

  • Identified method for analyzing chemical data, provided assistance in the selection of statistical package and interpretation of statistical output.• Evaluated Conductance parameters using regression analysis (SAS) of chemical processes data.



Moscow Technical University of Railroad Transportation

• Director of Ukhta Campus

  • Jan 1995 - Sep 2001

  • Performed administrative work like coordination and organization of class schedules and exams; lead Admission Campaigns and entrance exams in Ukhta Campus.• Completed annual reports about students’ performance and professors’ workload. • Developed Student registration processing System 1997 - 1999Project components: Students registration for training, evaluation based on performance, scheduling courses, accounting professors’ workload. The project was implemented as a MS Access 6.0 application for small local campuses and as Client server application with Oracle as backend and C++ as front end for main Moscow Office.• Designed the Application logic, Reporting, Unit Testing and Documentation.

• Associate Professor of Physics and Chemistry

  • Feb 1989 - Dec 2000