Create Reviewer's Guide for SDTM and ADaM
Participate in automate the creation of SDTM/ADaM datasets
CRO Management of the CDISC related activities for outsourced studies.
Mentor junior programmers
Become involved with process improvement and initiatives
Participate in developing and implementing Standard Operating Procedures and Guidelines for all aspects of CDISC SDTM/ADaM/Define.xml programming and quality deliverables development
(degree / diploma) Bachelor or Master Degree required, any statistics/biostatistics degree preferred, but not required.
Experience - 8-10 years clinical trials in pharma or CRO. In depth SAS programming knowledge.
Knowledge and Skills (Functional / Technical)
Hands-on experience on multiple CDISC projects (10 or more studies) and Written Reviewers Guide with CDISC package.
Working knowledge with SDTM/ADaM/XML
Familiarity with statistical methods used for biomedical/pharmaceutical research required;
Experience with clinical trials or pharmaceutical industry experience required;
Knowledge of current industry and regulatory submission practices, protocol designs, and terminology.
Excellent communication skills
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