Hicham EL FARRI

-Managed and coordinated up to 3 global programming teams across parallel oncology and neuroscience projects, delivering analysis-ready datasets for 13+ pivotal clinical trials each year. -Orchestrated and led global workshops to enhance colleagues' statistical programming expertise, enabling 9 individuals to contribute to statistical programming activities post-workshop. -Developed and implemented SAS and R programs, along with their specifications, to produce ADAM datasets. -Developing a novel R Shiny tool to support the visualization and quality control (QC) of clinical data, with integrated consistency checks designed to significantly reduce QC resources and clinical issues, accelerate the QC process, and enhance data reliability. -Represented Roche at industry events, including PHUSE, to share expertise, exchange knowledge, and foster collaboration within the statistical programming and data science community.

- Analyzing phase I to III Clinical trials in different indications within the Oncology Business unit. - Writing the ADAM specifications and program derived datasets following the CDISC standards. - Review of SDTM datasets and specifications created by the data management team. - Developing SAS programs and macros to generate tables, listing and graphs for scientific reports and publications. - Writing the Reviewer’s Guide. - Programming point of contact with data management and clinical teams. - Review of open CDISC checks. - Validation activities such as developing acceptance checks and quality control of outputs and programs.

Responsible for : Analyzing phase I to IV Clinical trials (demography, safety and efficacy) in different therapeutic area. Write the ADAM specifications following the CDISC standards from the annotated CRF and the SAP Design and Program ADAM derived datasets using SAS Base, Macro, Stat SQL and Graph Production of tables, listings & figures Writting technical documents like Reviewer’s Guides - Creating Analysis datasets in the ADAM standard - Creating ADAM mapping - Creating SAS programs and macros in order to prepare ADAM datasets and Tables, Figures and Listings (Phase I, II and III). - Doing quality control of Dataset and Mapping - Writing technical documents like Reviewers Guides.

- Creation and validation of tables, listings and graphs - Creation and QC of macros and reports - Use of CDISC - Redaction of TFL - Review of SAP - Knowledge of GCP and ICH Guidelines - Electronic archiving documents - Writing of technical documents - Respect of quality commitments - Participating in the continual improvement of the Quality System - Identifying and to record non conformities

- Developing programs through SAS software (Base, Macro, SQL and Graph) in order to controm accounting flows coming from our partners - Extracting data through Business Object and creating query - Creating and automating management tools with VBA and Access - Management Project

- Studying the academic backgrounds of the students in the Aix-Marseille academy - Using statistical methods such as linear regression, logistic regression, CAH, ACP with SAS and SPSS - Developping programs through SAS software (Base, Macro and Stat) in order to analysis the academic backgrounds