Job Description

The role of the Associate Director is to manage statistical programming activities within a Statistical Programming team, ensuring that all statistical programming activities are appropriately planned and executed for assigned Phase I-IV clinical studies sponsored by Allergan, plc.  This high-ranking level position serves as a compound lead, independently performs statistical programming for clinical studies and integrated summaries, and prepares responses to requests from regulatory authorities. The Associate Director may provide statistical programming expertise on departmental and cross-functional process improvement initiatives. Other responsibilities include but are not limited to: coordinating responses to regulatory authorities, and managing projects with partner and functional service providers (FSP).

• Provide programming and documentation support for multiple studies with good quality

• Review statistical analysis plans for all assigned studies and integrated summaries 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
• Coordinate own task assignments
• Support urgent regulatory agency requests
• Participate in Statistical Programming process improvement initiative
• Lead the Statistical Programming submission support, including managing timelines, tasks, and resources
• Contribute to cross-functional process improvement initiative(s)

In addition, the incumbent is the key contact for within and outside of R&D including Clinical Development, Clinical Pharmacology, Device, Drug Development Operations, Project Management & Planning, Regulatory Affairs & Medical Writing, Data management. External interfaces include: contract research organizations
 

Qualifications
 

• Master’s degree.  Major in Statistics or Mathematics is preferred.
•  At least 9+ years of relevant experience in pharmaceutical industry.