Biostatistics Senior Manager, Biosimilars Us- Remote

Amgen Australia Pty Ltd

Remote, US
Base: $154,104.15 - $208,493.85 usd; bonus: discre...
Fully remote
Doctorate or master's degree in biostatistics
Experience with biosimilars development
Expertise in non-inferiority or equivalence trials
Amgen is seeking a Biostatistics Senior Manager for their Biosimilars division, offering a fully remote position. The ideal candidate will lead statistical aspects of clinical activities and contribute to regulatory submissions, requiring extensive experience and knowledge in biostatistics, particularly in the pharmaceutical industry

Job Summary

  • This role leads statistical aspects of documentation for large product pipelines and complex studies in the biosimilars sector.
  • The successful candidate will oversee statistical work performed by CROs and ensure all analyses meet required regulatory standards.
  • Amgen offers a comprehensive benefits package including retirement plans, health coverage, and flexible work models.

Matching Summary

Match Score: 85

Amgen is seeking a Biostatistics Senior Manager for their Biosimilars division, offering a fully remote position. The ideal candidate will lead statistical aspects of clinical activities and contribute to regulatory submissions, requiring extensive experience and knowledge in biostatistics, particularly in the pharmaceutical industry.

Salary

Base: $154,104.15 - $208,493.85 USD; Bonus: Discretionary annual bonus program; Benefits: Retirement plan, health/dental/vision, stock incentives

Skills & Requirements

Must-have

  • Doctorate or Master's degree in Biostatistics
  • Experience with biosimilars development
  • Expertise in non-inferiority or equivalence trials
  • Statistical contributions to regulatory submissions
  • Leadership of complex clinical studies

Nice-to-have

  • Knowledge of adaptive designs
  • Experience with combined phase 1/2 or 2/3 designs
  • Ability to present at external scientific meetings
  • Collaboration within global teams
  • Publication record in scientific journals

Key Requirements

  • Doctorate degree with 2 years experience OR Master's with 6 years OR Bachelor's with 8 years
  • Masters or Doctoral degree in Statistics/Biostatistics preferred
  • Minimum 5-8 years post-graduate statistical experience in pharmaceutical industry
  • US work authorization required (Sponsorship not guaranteed)

Work Rights

Not specified

Tailored Resume

Cover Letter