Irina Minakova Email & Phone Number

Moscow, Russian Federation

• Participate in more than 50 clinical trials of wide range of therapeutic areas, mostly of phase 2-3. Participate in creating ISS/ISE reports, produce and QC randomization scheme and codes, produce materials to support.
• Produce derived datasets and advanced tables, figures and data listings using efficient programming techniques
• Apply statistical methods in writing SAP, reviewing CSR, creating/reviewing statistical outputs
• Coordinate and lead a project team to successful completion of a project within given timelines and budget
• Interact with clients as key contact with regard to statistical and contractual issues and leading the project
• Produce and QC of analysis plans, statistical reports, assisting in creating statistical sections of integrated clinical reports and other process supporting documents

performing the statistical analysis of the clinical trials data (II, III, IV phases) using SAS Software in accordance with ICH statistical regulatory requirements and GCP standards

statistical anaysis of microarray data

Master

Master