Software Engineer

• 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 or other programs and specifications for production of output to support study needs, including publications, safety reporting, and ad hoc analyses in a timely fashion.
• Demonstrate expertise in SAS language, procedures, and options commonly used in clinical trial reporting, including the Macro language, BASE SAS, SAS/STAT & SAS/GRAPH.
• Oversee and manage the work of other junior programmers.
• Develop and/or validate standard macros to automate output production.
• Adhere to company SOPs and department guidelines.
• Work concurrently on multiple projects.
• Troubleshoot technical and project issues.
• Help with the infrastructure development of the department.
• Communicate effectively with internal cross-functional groups and external partners.

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