Senior Manager, Statistical Programming

About the role

A Senior Manager Statistical Programming provides timely support to the project team on all programming matters according to the project strategies within a therapeutic area. As an integral part of a project team, the incumbent provides project leadership and contributes to the programming support for processing data from clinical studies.

Responsibilities

• Independently coordinate and oversee the preparation, execution, reporting and documentation of project analysis programming within a therapeutic area using appropriate tools to track, allocate and summarize extent of work required, progress and completion of programming deliverables.
• Manage and coordinate programming and QC of analysis datasets and TFLs following Regeneron standard data models and/or integration of data across studies in support of CSS/CSE and esub deliverables.
• Implement and mentor others on the use of department standardization tools or therapeutic area standard analysis when programming clinical data or system application deliverables.
• Contribute to programming development and quality control of the programming deliverables utilizing Regeneron tools and methodologies.
• Programming representative within a therapeutic area in a multidisciplinary study team to ensure timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch and annual reports. If applicable, programming representative for an application development to the user audience.
• Develop data models, programming standards and code, and train end users in the use of project standards to support programming deliverables that follow regulatory submission requirements.
• Mentor junior level staff in therapeutic area requirements. Develop collaborative work environment and be a positive role model.
• Advises all relevant employees about the procedures surrounding retention of data, records, and information for employees in their group.

Requirements

• Masters Degree and 8-10 years of relevant experience
• SAS Certification desirable.

Qualifications

To be considered for this role, you must meet the following requirements:

• Masters Degree and 8-10 years of relevant experience
• SAS Certification desirable.