Principal Statistical Programmer

General Summary:

The Principal Statistical Programmer works with management to delegate tasks appropriately, track progress, and provide expert technical support to team members. In addition, the Principal Statistical Programmer is a designated member of clinical sub-team(s) in the role of project lead Statistical Programmer.

Key Duties and Responsibilities:

• Works regularly with advanced features of SAS (including interfacing ability with other software applications and operating system tools)
• Performs quality control checks of SAS code and output produced by other Statistical Programmers to ensure accuracy and consistency within group
• Demonstrates in-depth knowledge of clinical development and medical data
• Solves complex clinical trial reporting problems and demonstrates technical proficiency and exercises judgment in supporting daily operations and ensuring that study tasks are completed accurately and in a timely manner
• Engages with a variety of other functions, including Statistical Programmers, Biostatisticians, Data Management, and other departments engaged in providing data and submission-related activities, often at Senior Management levels
• Creates all files, documents, and analyses necessary to support an electronic submission in eCTD format, including ISS/ISE
• Provides leadership to ensure compliance with Vertex SOP'S and FDA/ICH/GCP regulations
• Provides technical and project management skills to create, review, and approve documentation required to support data analysis, reporting, and CDlSC data submission
• Participates in project management cross-functional teams that work on standard operating procedures, guidelines, process improvements, system validation and acquisition, customization, and integration of new tools and technologies