Allergan Sr Mgr, Statistical Programming in Madison, New Jersey
Sr Mgr, Statistical Programming
Madison, New Jersey, United States at https://agn.referrals.selectminds.com/jobs/5278/other-jobs-matching/location-only
May 07, 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 Senior Manager is to manage statistical programming activities to ensure they are appropriately planned and executed for all assigned Phase I ‐ IV clinical studies sponsored by Allergan and its partners. This senior 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.
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 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
Lead the Statistical Programming submission support, including managing timelines, tasks, and resources
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
Participate in the evaluation and adaptation of new computing technology and programming practices related to statistical programming and systems development
Ensure analyses for multiple studies are consistent with standard templates and specifications
Oversee programming tasks for >=2 programs
Mentor more junior level staff
Support urgent regulatory agency requests
Participate in a Statistical Programming process improvement initiative(s)
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
Minimum four (4) years project management experience in statistical programming or related field
Excellent knowledge of SAS computer package and Unix/Linux computing environment
Knowledge of CDISC foundational standards
A thorough knowledge of good programming practices and methodology
Good 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 or with at least 6+ years’ experience in Statistical Programming preferred
Bachelor's degree least 8+ 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.