Methodology in the field of clinical research, epidemiology, outcomes research; regulatory strategy; support for discussions with the authorities, scientific committees, safety boards; manuscript preparation and review.


Sample size and power calculations; protocol statistical sections; statistical analysis plans for studies, meta-analyses, ISS/ISE, registries; data review, result presentations; statistical reports; interim analyses.


Statistical programming (derived data sets, tables, figures and listings); data mapping and pooling (CDISC SDTM/ADaM standards); SAS programs and macros validation; SAS 9.2, SPAD, SPSS, PASS.


Independent Statistical Center for IDMC and DSMBs; generation of randomization lists; exploratory analyses; sensitivity analyses; questionnaire validation (psychometric properties); data-mining including real-life data exploration.