Job Description
General Summary:
The Principal Statistical Programmer is a designated member of clinical sub-team(s) in the role of project lead Statistical Programmer. This role works with management to delegate tasks appropriately, track progress, and provide expert technical support to team members in support of Vertex's Immunotherapies program.
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 the 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 SOPs and FDA/ICH/GCP regulations
- Provides technical and project management skills to create, review, and approve documentation required to support data analysis, reporting, and CDISC 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
Knowledge and Skills:
- 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
Education and Experience:
- Bachelor's degree in a Scientific Discipline
- Typically requires 5+ years for M.S. or above and 8+ years for B.S. years of work experience in Biotech, Pharmaceuticals or Clinical Research Organization
Pay Range: $136,960 - $205,440
Flex Designation: Remote-Eligible
Company Information:
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.
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