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Senior Manager, Statistical Programming (Remote Flexibility))

Primary Madison, 新泽西州 Secondary 爾灣, 加利福尼亚州 职位 ID 2112566 类别 Research and Development 部门 AbbVie

Position Summary
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.

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.

Key Duties / Responsibilities
Role: Statistical Programmer Oversight: Low to Moderate

  • 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
  • Support urgent regulatory agency requests
  • Participate in a Statistical Programming process improvement initiative(s)
  • Participate in a Statistical Science and Programming process improvement initiative(s)
  • Contribute to cross‐functional process improvement initiative(s)

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.

 


Minimum Requirements
MS in statistics or equivalent with at least 6+ years experience in Statistical Programming supporting drug development, submission, and approval in the pharmaceutical/biotech/device industry or CRO Or Bachelor's degree with at least 8+ years experience in Statistical Programming supporting drug development, submission, and approval in the pharmaceutical/biotech/device industry or CRO

Minimum four (4) years project management experience in statistical programming or related field

Knowledge:

  • 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 regulatory guidelines regarding statistical programming
  • Proficient with Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, and Adobe Acrobat

Skills/Competencies:

  • Ability to support and prioritize multiple projects and the work of other statistical programmers
  • Ability to multitask
  • Ability to influence others without direct reporting relationships
  • Ability to take initiative
  • Demonstrated strengths in the following areas:
    • Oral and written communication skills
    • Planning and organizational skills
    • Decision making, judgement and problem solving skills
    •  Project management skills
    • Leadership Skills


Note: While this job description is intended to be an accurate reflection of the job requirements, management reserves the right to modify, add or remove duties from a particular job and to assign other duties as necessary and at any time.

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: No
Job Type: Experienced
Schedule: Full-time
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