Biostatistics Senior Manager, Biosimilars Us- Remote

Amgen UK

Remote, US
Base: $154,104.15 - $208,493.85 usd; bonus/equity:...
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Doctorate or master's degree in biostatistics
Experience with non-inferiority or equivalence trials
Statistical contributions to regulatory submissions
** Amgen UK is seeking a Biostatistics Senior Manager for their Biosimilars division, offering a fully remote position in the US. The ideal candidate will lead statistical contributions to clinical studies, ensuring the quality and accuracy of statistical documentation while adhering to regulatory standards. **

Job Summary

  • This role leads statistical aspects of documentation for large product studies and ensures all approaches meet required standards.
  • The successful candidate will oversee statistical work performed by CROs and provide inputs to regulatory documents including Clinical Study Reports.
  • Amgen offers a comprehensive benefits package including retirement plans, health coverage, and flexible work models for this remote position.

Matching Summary

Match Score: 75

** Amgen UK is seeking a Biostatistics Senior Manager for their Biosimilars division, offering a fully remote position in the US. The ideal candidate will lead statistical contributions to clinical studies, ensuring the quality and accuracy of statistical documentation while adhering to regulatory standards. **

Salary

Base: $154,104.15 - $208,493.85 USD; Bonus/Equity: Discretionary annual bonus and stock-based long-term incentives; Benefits: Comprehensive health, dental, vision, retirement plan, and flexible time-off

Skills & Requirements

Must-have

  • Doctorate or Master's degree in Biostatistics
  • Experience with non-inferiority or equivalence trials
  • Statistical contributions to regulatory submissions
  • Knowledge of adaptive design methodologies
  • Leadership of complex clinical study projects

Nice-to-have

  • Experience publishing applied research in journals
  • Ability to present findings at external meetings
  • Collaboration within global teams and CRO partners
  • Proactive communication of resource issues
  • Involvement in process improvement initiatives

Key Requirements

  • Doctorate degree plus 2 years experience OR Master's plus 6 years OR Bachelor's plus 8 years
  • Masters or Doctoral degree in Statistics/Biostatistics preferred
  • 5-8 years post-graduate statistical experience in pharmaceutical industry
  • Demonstrated ability to defend statistical findings internally and externally
  • Sponsorship not guaranteed

Work Rights

Not specified

Tailored Resume

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