– Design the CRF in electronic format in e-CRF
– Import the data into electronic databases
– Check the data and manage inconsistencies in the data entered
– Extract and transfer the data from the database
– Reflect on the experimental plan and working hypotheses in collaboration with doctors/veterinarians
– Carry out documentary research on study themes
– Define and develop appropriate statistical methodologies to apply in clinical studies
– Calculate the number of subjects necessary
– Develop the randomization list of subjects
– Write the statistical part in the protocol
– Design the statistical analysis plan
– Manage databases and create derived bases
– Program statistical analyzes using SAS ® software (SAS/BASE, SAS/MACRO, SAS/ODS, SAS/SQL) or R
– Create and validate standard macros under SAS ® or R
– Apply advanced statistical methods : inferential statistics (parametric and non-parametric), linear regression, analysis of variance, mixed models, generalized linear models, survival models.
– Generate outputs under SAS®: tables, listing, figures.
– Interpret and present the statistical results of clinical studies
– Write the statistical report
– Participate in the writing of publications, posters and abstracts
– Ensure the quality and integrity of statistical programs to meet current regulatory requirements and industrial standards
– Contribute to the development of SOPs in accordance with ICH-GCP