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CDISC Consultant (Remote) (Science & Biotech)
Home Based, CA 92075
Recruited by: DOCS Global | Senior Recruitment Consultant | DOCS Global Staffing See all my Jobs

  • Hiring Company: DOCS Global Staffing
  • Industry: Science & Biotech
  • Compensation: $DOE
  • Expires: Mar 23, 13
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Job Description

CDISC Consultant Basic Qualifications:
• BA/BS or higher degree in Computer Science, Statistics, Mathematics, Life Sciences, other related scientific subject
• 5 years of pharmaceutical/biotech industry experience
• 3 years of SDTM consulting experience – conformance assurance, standardization, harmonization, liaising, problem-solving
• In-depth knowledge on SDTM standard – official training from CDISC preferred
• Hands-on experience on CRF annotation with SDTM mapping
• Experience on managing SDTM controlled terminology – subscribing, updating, versioning
• Effective oral and written communication
• Good documentation practice
• Willingness and ability to learn and follow standard processes and procedures in team environment
• Ability to work proactively and independently
Key Responsibilities:
The CDISC Consultant will work in the CDISC Consultancy Group (CCG). The CCG is primarily responsible for supporting the compliant and consistent adoption of the CDISC Study Data Tabulation Model (SDTM). The role will provide SDTM consultancy support for new and ongoing studies and involve close collaboration with SDF Implementers, Biostatistical Programmers, and Global Librarians.

Responsibilities include (but are not limited to):
• Participate in SDF implementation and study team meetings to provide expert advice on SDTM mapping
• Resolve study level mapping issues in a timely manner and escalate global issues for CCG leadership discussion
• Contribute to team and process documentation
• Work with project manager and the Senior CDSIC Consultant to ensure timely deliverables for study milestones
• Follow standard convention to provide SDTM annotation on CRFs
• Work with Global Librarians to manage SDTM Controlled Terminology