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.
- Creates all files, documents, and analyses necessary to support an electronic submission in eCTD format, including ISS / Client.
- 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
Requirements :
- Proficiency in all SAS language, procedures, and functions commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS / STAT and SAS / GRAPH
- Intermediate knowledge of CDISC Standards
- Intermediate knowledge of clinical trials
- Regulatory submission experiences
- Effective communication (written and verbal) skills to explain difficult information
- Bachelor's degree in a Scientific Discipline
- Typically requires + for or above and + years for years of work experience in Biotech, Pharmaceuticals or Clinical Research Organization
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