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Mgr, Statistical Programming

Expired Job

Allergan, Inc. Irvine , CA 92606

Posted 4 months ago

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 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

  • 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

  • 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

Requirements

  • 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

  • Adobe Acrobat

Preferred Skills/Qualification

  • Minimum two (2) years project management experience in statistical programming or related field

Education

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.

  • LI-DM1
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Mgr, Statistical Programming

Expired Job

Allergan, Inc.