Allergan Mgr, Statistical Programming in Madison, New Jersey
Mgr, Statistical Programming
Madison, New Jersey, United States at https://agn.referrals.selectminds.com/jobs/6060/other-jobs-matching/location-only
Jul 23, 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 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.
The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan policies and procedures.
Main Areas of Responsibilities
· Provide programming and documentation support for multiple studies with good quality
· Reviewstatistical analysis plans for all assigned studiesand integrated summariesand 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
· 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 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.
· 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
The following listed requirements need to be met at a minimum level to be considered for the job:
· 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
· Good 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 Adobe Acrobat
· 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
· 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
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.