BioSpace · 2 days ago

Manager, Statistical Programming

United States

Full-time

Remote

Senior Level, Lead/Staff

$124K/yr - $203K/yr

8+ years exp

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Comp. & Benefits

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Responsibilities

Assist in providing mentorship in implementing and driving the programming and project standards. The evaluation and development of study requirements and validation plan are also in the scope of this position.

Design and test program logic, coding programs, program documentation and preparation of programs. Coordinates projects crafted 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.

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 achievements.

Proficiency in the integration of data across studies in support of CSS/CSE. Build, lead and maintain the programming specifications for the analysis datasets applying 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.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Statistical ProgrammingClinical Trial Data ProcessingProgramming SpecificationsData IntegrationSubmission Requirements ValidationRegulatory ComplianceProgramming Logic DesignQuality ControlDocumentation