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

179495Requisition #

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.

Position Overview

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

Requirements

  • 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

Preferred Skills/Qualification

  • 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

Education

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.