Jenni Woolley is recruiting for an SAS/SDTM Programmer to join a well established pharmaceutical company at their offices in Basel, Switzerland on a contract basis. This is a 12 months contract with potential extension.
The successful candidate must have the following experience, knowledge and skills:
- SAS advanced programming skills
- SDTM programming experience
- define.xml principles and concepts expertise
- experience in annotating CRF for SDTM
- Involved in a submission to Authorities in the past
- ADaM programming experience
- EDC systems programming experience (Rave, Inform, Marvin etc...)
Additionally the successful candidate should have the following experience, knowledge and skills:
- University degree (or equivalent) in mathematics, informatics, engineering or related disciplines or high school qualification
- Experience in programming of in a data management or biostatistics function of a pharmaceutical company or a clinical research organization
- 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
- Proficient in Microsoft Windows and Office
- Sound knowledge of clinical trial process
- Ability to communicate effectively in English
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and 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 CL41005 in all correspondence.
You MUST be eligible to work in Switzerland. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Posted: 11th January 2018
- Expires: 8th February 2018
- Reference: CL41005