Principal Statistical Programmer

Role Summary

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

In This Role, a Typical Day Might Include As an integral part of a study, the incumbent provides project leadership and programming support for processing data from clinical studies. Requirements will be identified according to a Statistical Analysis Plan and programming specifications using internal standards and guidelines. The incumbent assists in providing guidance in implementing and executing the programming and project standards. The evaluation and development of study requirements and validation plan are also in the scope of this position. Works independently to design and test program logic, coding programs, program documentation and preparation of programs. Oversees projects designed to support ongoing clinical studies requests for statistical and non-statistical analyses. Meets statistical adhoc requests of senior management. Provides documentation and consistent maintenance of code, logs, and output in a regulated environment.

Responsibilities

• Support and/or lead programmer for 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.
• Integration of data across studies in support of CSS/CSE. Create, manage and maintain the programming specifications for the analysis datasets utilizing Regeneron tools and methodologies.
• Support creation and validation of submission requirements (i.e. 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 the more complex data presentations.
• Participate in department working groups; provide input in development of tools and improvement of processes.

Qualifications

• Education: Masters Degree
• Experience: 3+ Years Experience
• SAS: Base, Stat, Macro, Graph

Skills

• Programming and QC of analysis datasets, TFLs or standard tools
• Data integration across studies and programming specifications management
• Submission materials creation and validation
• Statistical analysis support and ad-hoc request handling
• Documentation and code maintenance in regulated environments

Education

• Masters Degree

Additional Requirements

• None specified