Allergan Mgr, Statistical Programming in Madison, New Jersey
Mgr, Statistical Programming
Madison, New Jersey, United States at https://agn.referrals.selectminds.com/jobs/5267/other-jobs-matching/location-only
May 04, 2018Post Date
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 I‐IV clinicalstudies. This position serves as a program lead and/or study lead depending on the complexity and stageof the assignment and independently performs statistical programming for clinical studies, integratedsummaries, and in support of responses to requests from regulatory authorities.The employee must conduct their work activities in compliance with all relevant laws, regulations, andregulatory guidelines as well as all Allergan policies and procedures.
Main Areas of Responsibilities
Provide programming and documentation support for multiple studies with good quality
Review statistical analysis plans for all assigned studies and integrated summaries and provide commentsto 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
Review and author standard operating procedures and supporting documents related to StatisticalProgramming 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 initiative
Manage timelines and ensure good communication with CROs/FSPs and internal programmers
Conduct high level review of deliverables provided by CRO/FSP to ensure good quality and accuracy
Oversee programming tasks for multiple studies
Ensure analyses for multiple studies are consistent with standard templates and specifications
Oversee programming tasks for 1 program
Ensure analyses for all studies within a program are consistent with program defined standard templatesand specifications
Mentor/oversee more junior level staff
Knowledge of SAS computer package
Good working knowledge of Unix/Linux operating system
Understanding of CDISC foundational standards
A thorough knowledge of good programming practices and methodology
Knowledge of clinical trial methodologies, drug development, and FDA GCP/ICH regulatoryguidelines regarding statistical programming
Proficient with Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, andAdobe Acrobat
MS in statistics with 4+ years’ experience in Statistical Programming preferred
Bachelor's degree with 6+ years’ experience in Statistical Programming required
Equal Employment Opportunity Employer
Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.