Principal Statistical Programmer

About the role

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

Responsibilities

• Works regularly with advanced features of SAS, including interfacing 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.
• Demonstrates in-depth knowledge of clinical development and medical data.
• Solves complex clinical trial reporting problems and demonstrates technical proficiency while exercising judgment in supporting daily operations.
• Engages with Statistical Programmers, Biostatisticians, Data Management, and other departments involved in 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 for data analysis, reporting, and CDISC data submission.
• Participates in cross-functional teams working on standard operating procedures, guidelines, process improvements, system validation, and integration of new tools and technologies.

Requirements

• Proficiency in SAS language, procedures, and functions commonly used in clinical trial reporting, including Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH.
• Intermediate knowledge of CDISC Standards.
• Intermediate knowledge of clinical trials.
• Regulatory submission experience.
• Effective written and verbal communication skills.

Qualifications

• Bachelor’s degree in a Scientific Discipline.
• Typically requires 5+ years of work experience for M.S. or above, and 8+ years for B.S. in Biotech, Pharmaceuticals, or Clinical Research Organization.

Pay

$149,200 - $223,800 base salary. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements.

Benefits

• Medical, dental, and vision benefits.
• Generous paid time off, including a week-long company shutdown in the Summer and Winter.
• Educational assistance programs, including student loan repayment.
• Generous commuting subsidy.
• Matching charitable donations.
• 401(k) retirement plan.

Schedule

This is a Remote-Eligible role with flexible options:

• Remote: Work remotely five days per week with occasional office visits.
• Hybrid: Work remotely up to two days per week.
• On-Site: Work five days per week on-site with ad hoc flexibility.

Note: Flex status is subject to Vertex’s Policy on Flex @ Vertex Program and may change.