Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.
We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.
For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.
Responsibilities :
Design and Develop R packages to support metadata driven SDTM automation
Develop & Implement CDISC SDTM & ADaM datasets in R
Scope to act as technical adviser and lead developer for all R packages of the project
Participate in the end to end development of the packages, incl. writing proper documentation, and unit and integration tests
Manage package versioning in GitLab
The candidate will perform hands-on programming development tasks using R and collaborate with the team of software engineers and submit and perform code reviews using GitLab
Support the team in open-sourcing the packages
Profile :
At least 6 years of professional experience
Solid experience implementing CDISC Standards (SDTM/ADaM).
Experience in working in early phase or Late phase clinical studies performing Regulatory reporting activities (SDTM, ADaM) using SAS or R i
Good knowledge about the end to end clinical reporting and adherence to sponsor standards. SDTM Pooling experience.
Submissions experience utilizing define.xml and other submission documents
R package development Requirements: Experience in software development using R
Advanced knowledge of the R Programming language including R package development, R-markdown, and R Studio
Understanding of open-source software development
Critical thinking and ability to supervise the development of several R packages
Excellent communication skills – communication with experts & non-experts.
Full remote position from any country in Europe
To be filled ASAP