Manager Statistical Programming

Role Summary

A Manager Statistical Programming provides timely support to the study team on all programming matters according to project strategies. They provide project leadership and programming support for processing data from clinical studies, lead the programming aspect of projects from single studies through regulatory approval and product launch, and oversee documentation and code maintenance in a regulated environment. They respond to statistical ad hoc requests from senior management and provide guidance on implementing programming standards.

Responsibilities

• Develop an expertise within a therapeutic area or standard tool. Work with minimal supervision to perform, coordinate and oversee the preparation, execution, reporting and documentation of a project
• Function as a lead programmer in the development and QC of tables, listings, graphs, or systems in support of analysis requirements utilizing Regeneron tools and methodologies and current industry standards (i.e. CDISC SDTM / ADaM)
• Manage the effort, including e-submission deliverables, using appropriate tools to track, allocate and summarize extent of work required, progress and completion of programming deliverables. Provide programming support for complex presentations and more complex statistical ad-hoc requests.
• Act as programming representative 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, lead an application development and act as the programming representative to the user audience.
• Work with management to determine resource requirements for therapeutic area or department function responsibilities.
• Review and select resumes, screen and interview candidates for contractor and permanent positions.
• Provide feedback to management regarding team member’s contributions to the work effort for evaluating individual's performance and recommend yearly goals.
• Advises all direct reports about the procedures surrounding retention of data, records, and information for employees in their group.

Qualifications

• Master’s Degree
• 8-10 years of relevant work experience
• SAS Certification desirable
• 5+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry, including some project and people management experience with a Master’s Degree in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline.