Location
Nouvelle Aquitaine | France
Job description
I. Excelya
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 900 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.
II Main responsibilities
The mission of the statistical programmer consists, in close collaboration with the Statisticians and Data-managers, of carrying out programming tasks in SAS software (or R software) and writing the associated documentation within the framework of clinical trials, data pooling or submission dossiers, mainly in oncology, while respecting the deadlines set, compliance with the regulatory texts and the applicable procedures.
The following is an overview of the possible tasks to be assigned to Statistical programmer
- Develop and maintain SAS programs to create SDTM, ADaM (or AD) datasets, TFLs, data review listings, patient profiles…
- Perform QC on raw data, SDTM datasets, ADaM datasets, TFLs, or any other deliverables
- Develop or review specifications for SDTMs and ADaM datasets
- Produce or generate all technical documentation for SDTM or ADaM such as Define XML, Reviewers Guides, Complex Algorithm, Pinnacle 21 report
- Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications
- Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities
- Provides comments about programming in the Sponsor QC Tracker
- Identify processes within programming that will increase productivity, quality and efficiency
- Follow applicable SOPs, Working Instructions, User Guides and relevant regulatory guidelines (e.g. ICH)
- Transfers deliverables
- Participate to transversal activities:
- Write, review, comment SOPs, Working Instructions, User Guides…
- Program, test and document global utility programs and tools in accordance with standards and validation procedures
III. Qualifications
- At least 1 year of SAS programming
- Programming under SAS software with a good knowledge of SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/MACRO
- Knowledge of CDISC SDTM and ADaM
- Good understanding of DM processes
- Ability to manage contractors and to handle time management of multiple simultaneous projects
- Excellent communication skills and leadership ability
- Fluency in English
Job tags
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