Manager Statistical Programming

About the role

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.

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 esubmssion 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.
• Lead an application development and act as the programming representative to the user audience.
• 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.

Requirements

• Master’s Degree
• 8-10 years of relevant work experience
• SAS Certification desirable

Qualifications

• 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.

Skills

• Expertise within a therapeutic area or standard tool.
• Ability to work independently and with minimal supervision.
• Experience in managing and tracking project efforts.
• Knowledge of industry standards (i.e. CDISC SDTM / ADaM).
• Strong programming and analytical skills.
• Ability to communicate effectively with cross-functional teams.
• Experience in clinical trial data processing.

Benefits

Not specified.

Pay

$128,600.00 - $210,000.00 annually

Schedule

Not specified.