Job Description
Provide oversight development of datasets (SDTMs/ADaMs) in CDISC-compliant format by CROs, including clear documentation of the process that was followed in the form of specifications, trackers, and checklists. Generate and/or review SDTM mapping specifications, annotated CRFs, ADaM specifications, define.XML documents, and reviewers’ guides per CDISC and FDA specifications and guidelines. Accountable for oversight of statistical programming deliverables for in-house and outsourced projects. Provide technical leadership, problem-solving of moderate to high complexity, and within project timelines while providing high-quality deliverables. Independently develop SAS programs and specifications for output to support study needs. Oversee and manage the work of other junior programmers. Troubleshoot technical and project issues.
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.