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.

Responsibilities

• As an integral part of a study, provides project leadership and programming support for processing data from clinical studies. Requirements identified according to a Statistical Analysis Plan and programming specifications using internal standards and guidelines. Assists in providing guidance in implementing and executing the programming and project standards. Evaluates and develops study requirements and validation plans. 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.

Qualifications

• Required: Masters Degree
• Required: SAS (Base, Stat, Macro, Graph)
• Experience: 3+ Years Experience

Skills

• Programming and QC of analysis datasets, TFLs or standard tools following Regeneron standard data models or user requirements
• Integration of data across studies in support of CSS/CSE
• Creation, management and maintenance of programming specifications for analysis datasets
• Support creation and validation of submission requirements (annotated CRF, data export files, define documents)
• Multidisciplinary study team collaboration for timely and quality support for analysis and reporting of clinical trials up to regulatory approval
• Ad-hoc reporting and basic presentations; capacity to assist with more complex data presentations
• Participation in department working groups and tool/process improvement

Education

• Masters Degree

Additional Requirements

• On-site work expectations as required by Regeneron policies