Senior Statistical Analyst

Responsibilities:

The role of the Senior Statistical Programmer is to perform statistical programming activities

for all assigned Phase II-IV clinical studies sponsored by AbbVie and its partners. This position performs statistical programming for clinical studies, integrated summaries, and in support of responses to requests from regulatory authorities.  This position will serve as a study lead for an assigned study.

• Provide programming and documentation support for multiple studies with high quality
• Review statistical analysis plans for all assigned studies and integrated summaries in conjunction with program lead and provide comments to study biostatistician
• Create ADaM data set specifications for all assigned studies and integrated summaries
• Ensure study analysis is consistent with standard templates and specifications
• Contribute to submission support
• Follow timelines for assigned study tasks
• Contribute to development of new standard templates
• Participate in development of standard operating procedures and supporting documents related to Statistical Programming processes
• Coordinate own task assignments
• Support urgent regulatory agency requests
• Participate in a Statistical Programming process improvement initiative

In addition, the incumbent is one of the key contacts for Statistical Science and Data Management and Clinical Programming.  External interfaces include: contract research organizations (CRO), functional service providers (FSP), and other vendors or consultants.

Minimum Requirements

• Bachelor’s or Master Degree. Major in Statistics, Mathematics, or Engineering is preferred
• Three to five years experience required