– Design of the CRF in electronic format in e-CRF
– Importation of data into electronic databases
– Data control and management of inconsistencies in the data entered
– Extraction and transference of data from the database

– Analysis/development of the experimental plan and the working hypotheses in collaboration with the doctors/veterinarians
– Researching on the subject of the study
– Definition and development of adequate statistical methodologies to be applied in clinical studies
– Calculation of the number of patients needed for the study
– Development of the randomization list of patients
– Development of the statistical part in the study protocol
– Design of the statistical analysis plan

– Management of databases and creation of derived databases
– Program statistical analysis using SAS ® software (SAS/BASE, SAS/MACRO, SAS/ODS, SAS/SQL) or R
– Creation and validation standards macros under SAS® or R
– Application of advanced statistical methods: inferential statistics (parametric and non-parametric), linear regression, analysis of variance, mixed models, generalized linear models, survival models.

– Generation of outputs under SAS®: tables, listing, figures.
– Interpretation and presentation of the statistical results of clinical studies
– Development of the statistical report
– Preparation of publications, posters and abstracts

– Ensuring quality and integrity of statistical programs to meet current regulatory requirements and industry standards

– Contribution to the development of SOPs in agreement ICH-GC