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Senior Manager, Biostatistical Programming

Amgen

Amgen seeks a Senior Manager of Biostatistical Programming to lead offshore statistical programming teams in Hyderabad, overseeing end-to-end clinical trial programming activities, regulatory submissions, and global strategy implementation across product areas.

Responsibilities

  • Lead offshore team of Study Lead Programmers and Study Programmers on end-to-end programming execution
  • Ensure delivery of statistical programming milestone analyses and regulatory submission packages for assigned products
  • Develop and implement programming strategies, functional standards, and industry requirements globally
  • Monitor project progress, manage resources, and address programming issues at product level
  • Coach and mentor local programming staff and support their career development

Requirements

  • Bachelor's degree or higher in biostatistics, statistics, mathematics, or related quantitative field
  • Minimum 8 years of statistical programming experience in clinical development
  • Advanced SAS proficiency including STAT, Macro, Graph, and SQL
  • Experience leading and developing offshore statistical programming teams
  • Prior regulatory submission experience for drug approval
  • Strong leadership, communication, and project management skills
  • Experience with data quality compliance and software development processes
Vacancy posted 15 days ago
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