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Job Details

SDTM Specialist - 12 month contract

Company: Key People Limited
Location: Basel
Reference: BBBH23029
Closing Date: 20 Feb 18
Type: Contract
Salary (£): 100,000+
Benefits:

Job Summary:

An excellent opportunity has arisen for an experienced SAS Programmer to join a leading Swiss based Pharmaceutical company on a 12 month contract basis. The ideal person will have a strong SDTM background and at least 3 years of SAS Programming experience.

Requirements:

An excellent opportunity has arisen for an experienced SAS Programmer to join a leading Swiss based Pharmaceutical company on a 12 month contract basis. The ideal person will have a strong SDTM background and at least 3 years of SAS Programming experience.

Experience Required:

• University degree (or equivalent) in mathematics, informatics, engineering or related disciplines or high school qualification
• At least 3 years’ 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
• SAS Base Programmer Certificate and SAS Advance Programmer Certificate would be a strong asset (for not certified candidate passing these certificates will be expected shortly after employment)
• Good knowledge of data management principles, tools and processes
• Good understanding of LAB and other third-party data
• Good knowledge of clinical coding process, good knowledge of MEDDRA, WHODDE dictionaries formats.
• Very good knowledge and extensive experience in working with CDISC/SDTM standard including all areas (creation of Annotated CRF, Programming Specs, creation of Define.xml, programming and validating SDTM domains, writing Reviewers Guide, preparation of SDTM package for the submissions). Candidate should have a working experience with several versions of SDTMIG, TAUGs, different indications, and specific CDISC requirements from regulatory agencies.
• Good knowledge of 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

For further details on this role, or to discuss other vacancies, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@keypeople.co.uk

Apply for this job: SDTM Specialist - 12 month contract

Contact Information:

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Catherine House
Adelaide Street
St Albans
Hertfordshire
AL3 5BA
England
Tel:  Tel: 44 (0) 1727 811634
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Website:  Visit Our Web Site

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