Principal Statistical Programmer

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.

• 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

• 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 and regulatory submission experiences
• Effective communication (written and verbal) skills to explain difficult information

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

Pay Range: $149,200 - $223,800. The 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.

Remote‑Eligible Flex Eligibility Status:

• 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

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. Vertex is an E‑Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at A