Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.
The role of the Manager is to perform statistical programming activities for all assigned Phase IIV clinical
studies. This position serves as a program lead and/or study lead depending on the complexity and stage
of the assignment and independently performs statistical programming for clinical studies, integrated
summaries, and in support of responses to requests from regulatory authorities.
Main Areas of Responsibilities
Provide programming and documentation support for multiple studies with good
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
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
Review and author 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(s)
Participate in a Statistical Science and Programming process improvement
Knowledge of SAS computer package
Good working knowledge of Unix/Linux operating system
Knowledge of CDISC foundational standards
A thorough knowledge of good programming practices and methodology
Exceptional knowledge of clinical trial methodologies, drug development, and FDA GCP/ICH regulatory
guidelines regarding statistical programming
Proficient with Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, and
MS in statistics or equivalent with at least 4+ years' experience in Statistical Programming supporting
drug development, submission, and approval in the pharmaceutical/biotech/device industry or CRO is preferred.
Bachelor's degree with at least 6+ years' experience in Statistical Programming supporting drug development, submission, and approval in the pharmaceutical/biotech/device industry or CRO is required.