Principal Statistical Programmer

About the Role

A principal statistical programmer provides timely support to the study team on all programming matters according to the project strategies.

Responsibilities

• Provide project leadership and programming support for processing data from clinical studies as an integral part of a study.
• Identify requirements according to a Statistical Analysis Plan and programming specifications using internal standards and guidelines.
• Assist in providing guidance in implementing and executing the programming and project standards.
• Evaluate and develop study requirements and validation plans.
• Work independently to design and test program logic, code programs, document programs, and prepare programs.
• Oversee projects designed to support ongoing clinical studies requests for statistical and non-statistical analyses.
• Meet statistical ad-hoc requests of senior management.
• Provide documentation and consistent maintenance of code, logs, and output in a regulated environment.
• Support and/or lead programming and QC of analysis datasets, TFLs, or standard tools following Regeneron standard data models or user requirements.
• Assist in the coordination of activities and communicate shifting timelines and milestones.
• Integrate data across studies in support of CSS/CSE.
• Create, manage, and maintain programming specifications for analysis datasets utilizing Regeneron tools and methodologies.
• Support creation and validation of submission requirements (e.g., annotated CRF, data export files, define documents).
• Work in a multidisciplinary study team to provide timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch, and annual reports.
• If applicable, develop and provide department training for applications and standard tools developed by the department functions group.
• Provide programming support for simple presentations and basic statistical ad-hoc requests; assist in more complex data presentations.
• Participate in department working groups; provide input in development of tools and improvement of processes.

Qualifications

• Master's Degree
• SAS (Base, Stat, Macro, Graph)
• 3+ years experience

Pay

Salary Range (annually) $109,900.00 - $179,300.00