Responsibilities
Ø Preparation of SAS database specifications for studies assigned
Ø Evaluate external data source for integration to the clinical database
Ø Oversees / completes planning and construction of SDTM datasets for assigned studies
Ø Evaluate SDTM dataset compliance for studies that have been outsourced to CRO
Ø Oversees / completes planning and construction of Define.xml for assigned studies
Ø Evaluate Define.xml dataset compliance for studies that have been outsourced to CRO
Ø Constructs datasets in support of regulatory reporting requirements (DSMB, DSUR, IND)
Ø Constructs data listings in support of blind review meeting
Ø Reviews Case Report Forms and Data Validation Plans to ensure consistency with database standards
Ø Acts as the subject matter expert for regulatory requirements for the submission of electronic data
Qualifications:
Ø B.A. / B.S. degree in a related field.
Ø Extensive clinical data programming (SAS) experience
Ø Documented and recent experience in CDASH, CDISC & SDTM standards
Ø Functional knowledge of OpenCDISC software
Ø Functional knowledge of ADaM dataset structure preferred
Ø Functional knowledge of Medidata Rave preferred
Ø Self-motivated, willing to learn and demonstrates success at current job
Ø Excellent people and communication skills (written and oral)
Ø Extensive experience and understanding of third-party data
Ø Possesses a positive attitude and works well with others from different backgrounds and cultures.
Ø Documented experience in all areas of database set-up and programming for clinical studies.
Ø Demonstrated programming and logic skills.
David
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