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Biostatistics Senior Manager

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Amgen

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Location:
United States

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Category:
IT - Software Development

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Contract Type:
Not provided

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Salary:

154104.15 - 208493.85 USD / Year
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Job Description:

The Senior Biostatistics Manager independently leads sophisticated studies and projects in the General Medicine therapeutic areas (Cardiometabolic, Inflammation, Nephrology, and Neuroscience), ensuring that the statistical aspects of clinical activities meet required standards and are robust and valid. Will also influence and supply to strategy development, defend statistical approaches and represent GBS (Global Biostatical Science) through participating in and collaborating with multidisciplinary project teams.

Job Responsibility:

  • Utilizing knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, reimbursement, and medical affairs
  • Implementing, managing and supporting standards, technical quality and consistent approaches in strategy, study design and statistical analysis
  • Planning and executing statistical contributions to protocols, Flash Memos and Clinical Study Reports (CSRs)
  • Providing input for clinical publications and regulatory filing documents
  • Leading all aspects of work performed by study statisticians
  • Performing statistical and exploratory analysis of studies/projects and developing conclusions and recommendations
  • Anticipating and communicating resource and quality challenges that could impact results or timelines
  • Solid understanding of regulatory guidelines in drug development
  • Staying current in developments in the field of statistics in drug development (innovative trial design) and Amgen’s statistical policies, procedures and strategies
  • Contributing to process improvements and operational efficiencies

Requirements:

  • Doctorate degree in Statistics/Biostatistics or related subject with high statistical content and at least 2 years of Biostatistics experience
  • Master’s degree in Statistics/Biostatistics or related subject with high statistical content and at least 4 years of Biostatistics experience
  • Bachelor’s degree in Statistics/Biostatistics or related subject with high statistical content and at least 6 years of Biostatistics experience
  • Associate’s degree and 10 years of experience
  • High school diploma / GED and 12 years of experience

Nice to have:

  • Doctorate degree in biostatics or statistics
  • 5 or more years of pharma/biotech statistical experience
  • Life cycle drug development experience (pre-clinical, clinical and post-marketing)
  • Experience with cardiovascular drug development
  • Proven in leadership and motivating multi-functional team to advance complex projects to completion and thoughtfully negotiate and influence
  • Strong verbal and written communication combined with organizational skills and cross-cultural sensitivity
  • Statistical leadership and contribution to regulatory and reimbursement submissions
  • Strong working knowledge of theoretical and applied statistics and of regulatory guidelines
  • Experience working effectively in a globally dispersed team environment with cross-cultural partners
What we offer:
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible

Additional Information:

Job Posted:
May 06, 2026

Employment Type:
Fulltime
Work Type:
Remote work
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