Principal Statistical Programmer

Role Description

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 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.

Qualifications

• 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.

Requirements

• Bachelors 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.

Benefits

• Annual bonus and annual equity awards.
• Some roles may also be eligible for overtime pay, in accordance with federal and state requirements.
• Inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey.
• Medical, dental and vision benefits.
• Generous paid time off (including a week-long company shutdown in the Summer and the Winter).
• Educational assistance programs including student loan repayment.
• Generous commuting subsidy.
• Matching charitable donations.
• 401(k) and so much more.

Flex Designation

Remote-Eligible

Flex Eligibility Status

In this Remote-Eligible role, you can choose to be designated as:

• Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site;
• Hybrid: work remotely up to two days per week;
• On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.