About the Role:
Laura Christie is recruiting for a SAS/SDTM Programmer; to join a well established biotechnology company at their offices in Basel, Switzerland on a contract basis. This is a 12 months contract that can potentially be extended.
Main duties and responsibilities:
• Very good knowledge of SAS programming language including SAS/MACRO
• Good knowledge of data management principles, tools and processes
• Good understanding of LAB and other third-party data
• Very good knowledge and extensive experience in working with CDISC/SDTM standard including following areas:
o Creation of Annotated CRF, Programming Specs, Define.xml
o Programming and validating SDTM domains
o Writing Reviewers Guide
o Good knowledge of SDTM related specific regulatory requirements
• Knowledge of international clinical research regulations and requirements (e.g. ICH/GCP) and 21 CFR Part 11
· BSc or MSc in computer science, mathematics, statistics or life sciences
· Solid experience in programming in a data management function of a pharmaceutical company or a clinical research organization
· Good knowledge of programming languages and knowledge of data management principles and tools Experience with CDMS and understanding of LAB and other third-party data Proficient programming skills in Medidata RAVE environment
· Knowledge and experience using C# Programming for RAVE custom function
· Experience and understanding of CDISC standards
· Experience with Clinical Data Management System, including: Standard Library, Architect, Edit Checks; Database build, Validations/Derivations, Coding, Discrepancy Database/Querying; Standardization modules, data reporting tools; Develop/maintain global data standards
· Knowledge of international clinical research regulations and requirements (e.g. ICH/GCP) and 21 CFR Part 11
· Sound knowledge of clinical trial process
· Experience in maintaining and supporting data management and biostatistics processes in a distributed client base within a regulated environment
· Fluent in written and spoken English
For more information or to apply for this role, please contact Laura Christie on [... Click Apply...]928 or email [... Click Apply...]. Alternatively, please click on the link below to apply online.
CK Clinical is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL37827 in all correspondence.