Société : Argenx Lieu : Ghent Flanders Site source : Talent BE
Designing, building and improving the statistical programming environmentDevelopment of supporting toolsThe role will report into the Head of Quantitative Sciences.ROLES AND RESPONSIBILITIESManages timelines and in-house programming resources across projects, indications and studies or ad-hoc tasksParticipates in project team meetings.Provides relevant input in the development of the CRF, statistical analysis plan andmock tables, listings and figures.Supports outsourcing programming activities and oversees the QC of these activitiesDevelops programs to perform QC of statistical outputs.Performs critical review of derived dataset specifications and derived datasets(ADaM).Defines program specific standards for ADaM datasets.
Checks compliance of CROdelivered ADaM datasets to CDISC standards.Verifies define.xml (for ADaM's) and ADRG.Develops, validates and documents programs for additional analyses.Develops, reviews, documents and performs validation of generic SAS macros insupport of SAS programming environment.Supports data submission activities according to regulatory guidelines (e.g.
ISS, ISE).SKILLS ANDCOMPETENCIESExpertise with diverse statistical software packages such as SAS and ADaM.Thorough knowledge of and experience with CDISC standards.Knowledge of R is a plus.Ability to plan and execute the statistical programming tasks for multiple clinical trials and integrated analyses (e.g., ISS, ISE).Good communication skills and proficiency to work independently and as part of a team.Knowledge of ICH-GCP and other applicable legislation, with good understanding ofclinical data and pharmaceutical development.Experienced witEDUCATION, EXPERIENCE AND QUALIFICATIONSBachelors or higher degree in Science, Statistics, Information Technology or equivalent combination of education and related work experience.Excellent knowledge of SAS and R.Minimum of 10 years of professional experience.Experience in Biotech, in managing CROs and vendors is a plus. Argenx GhentFlanders
