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Title:Manager, Programming
Location:CA - Irvine


Plans, organizes, and manages the activities of a Statistical Programming group in support of clinical projects across multiple therapeutic areas.

  • Ensures all statistical programming functions meet ICH/GCP quality requirements in the support of product development and life cycle maintenance.
  • Contributes to activities in statistical systems development, validation and implementation including Standard Reporting Systems, SAS macro utility programs and associated tools.
  • Develops and oversees implementation of programming standards and conventions.

  • Degree and experience in Computer Science, Statistics, or related field.
    • At least eight (8) years of pharmaceutical experience with a masters degree or equivalent.
    • At least six (6) years of pharmaceutical experience with a Ph.D. degree or equivalent
  • Four to six years of leadership role in a technical and/or statistical programming environment in a pharmaceutical or biotechnology environment. Minimum of two years in a management position in a multi project environment with resource, timeline and budgetary responsibilities
  • Project Management experience in a global clinical trial environment
  • Experience in the development and implementation of global statistical programming standards and conventions
  • Excellent knowledge of clinical trial methodology and emerging global programming and data interchange standards
  • Demonstrated technical abilities and skills particularly in statistical software packages (e.g. SAS, S Plus)
  • Ability in programming system development and validation
  • Leadership, analytical, problem solving and technical skills
  • Demonstrated organizational, verbal, written and interpersonal skills
  • Excellent ability to work on multiple projects with competing priorities
  • Ability to travel 5 to 10 percent

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