Essential Functions of the Job:
• Technically lead and project manage multiple studies, managing all aspects of study deliverables related to statistical and clinical programming, as needed.
• Represent the Statistical Programming team at Study Management Team and Clinical Development meetings to address deliverables and timelines.
• Assess resourcing needs and support adequate staffing of projects.
• Assist in reviewing key study-related documents produced by other functions, including statistical analysis plans, case report forms, data management plans, database specifications, EDC data structures, DMC plans, and other clinical documents.
• Interact and communicate with Statisticians, Data Managers, Clinical Operations, Medical Monitors, Medical Writing, and other partners to address programming-related study deliverables.
• Write, test, and validate SAS programs to produce analysis datasets, tables, listings, graphs, and presentation outputs for regulatory submissions, publications, and other communications, as needed.
• Understand and execute department-, product-, and study-level macros and utilities; write, test, and validate product- and study-level macros and utilities.
• Serve as a technical resource for the programming group and provide advice on complex programming tasks and standards.
• Contribute to the development and review of Statistical Programming policies, standard operating procedures, and other controlled documents.
• Interface with outsourcing partners and vendors.
• Perform other duties as assigned.
Supervisory Responsibilities:
Individual contributor role. No direct people-management responsibility is specified. Provides technical leadership and project management for multiple studies, including resource planning and coordination with centralized teams, outsourcing partners, and vendors.