Manager Statistical Programming

Role Summary

A Manager provides timely support to the study team on all programming matters according to the project strategies. As an integral part of a study team, the incumbent provides project leadership and programming support for processing data from clinical studies. Requirements will be identified according to a Statistical Analysis Plan, programming specification or user requirements document using internal standards and guidelines. The incumbent provides guidance in implementing and executing the programming and project standards. The incumbent will be responsible for leading the programming aspect of a project, both internally or CROs, for all programming deliverables from the single study through to regulatory approval, product launch, data monitoring boards and annual reports. Oversees documentation and ensures consistent maintenance of code, logs, and output within a regulated environment. Meets statistical adhoc requests of senior management.

Responsibilities

• Develop expertise within a therapeutic area or standard tool; 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 (e.g., 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.
• Advise all direct reports about the procedures surrounding retention of data, records, and information for employees in their group.

Qualifications

• Required: 8–10 years with Master’s Degree
• Preferred: SAS Certification
• Also acceptable: 5+ years of programming experience in processing clinical trial data in 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.

Education

• Master’s Degree