Principal Statistical Programmer

Vertex Inc.•Boston, MA

1d•$149,200 - $223,800•Remote

About The Position

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. This role involves creating all files, documents, and analyses necessary to support an electronic submission in eCTD format, including ISS/ISE. The position provides leadership to ensure compliance with Vertex SOP'S and FDA/ICH/GCP regulations, and offers technical and project management skills to create, review, and approve documentation required to support data analysis, reporting, and CDISC data submission. The Principal Statistical Programmer 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
Bachelors degree in a Scientific Discipline
Typically requires 5+ for M.S. or above and 8+ years for B.S. years of work experience in Biotech, Pharmaceuticals or Clinical Research Organization

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