• Job Description

  Req#: R-210148

  Career Category

  Regulatory

  Job Description

  HOW MIGHT YOU DEFY IMAGINATION?

  You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

  Biostatistics Manager, Biosimilar Development

  The Biostatistics Manager in Biosimilar Development co-ordinates/performs the design, statistical analysis and reporting of individual studies, represents Biostatistics on study teams and provides statistical input for publications, presentations and in-house decision-making.

  Responsibilities

  • Provides statistical contributions, statistical review and quality control of Study Concept Documents (SCDs), protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph (TLG) shells, Submission Data File (SDF) specifications, other key-study related documentation, protocol deviations, Data Quality Review (DQR), Flash Memos, Clinical Study Reports (CSRs), clinical publications, and other communications in close partnership with CROs in a full-service CRO model.
  • Influences study design and defends statistical approaches internally and externally.
  • Ensures all statistical aspects of documentation pertaining to clinical activities meet required standards and are statistically correct.
  • Oversees the work of outsourcing partners and vendors for statistical services.
  • Performs statistical analysis of individual studies/projects and subsequent exploratory analyses and makes sound conclusions and recommendations.
  • Represents the Biostatistics function and participates in multidisciplinary project team meetings; collaborates closely with other functional team members; incorporates knowledge of cross-functional areas to inform and provide sound statistical guidance to teams (e.g. provide support and input in case report form design, and data collection)
  • Proactively anticipates and communicates resource and quality issues that may impact deliverables or timelines within functional area as well as cross-functionally.
  • Be familiar with statistical policy and strategy at Amgen; having working knowledge of theoretical and applied statistics and of regulatory guidelines and industry practice
  • Stays abreast of latest developments in the field of statistics in drug development and contributing to scientific advances by publishing applied research in scientific journals and books and presenting statistical methodology at internal or external scientific meetings.
  • Participates in the review of CRO Policies, SOPs and other controlled document development; contributes to process improvement and operational efficiency.
  • Adheres to all Amgen Policies, Standard operation procedures (SOPs) and other standards which are applicable to biosimilar development.

  Basic Qualifications

  Doctorate degree
  OR
  Master’s degree and 2 years of statistical experience
  OR
  Bachelor’s degree and 4 years of statistical experience
  
  OR
  Associate’s degree and 8 years of statistical experience
  
  OR
  High school diploma / GED and 10 years of statistical experience
  

  Preferred Qualifications

  • Master’s degree in Statistics/Biostatistics or other subject with high statistical content, and 2 years of post-graduate statistical experience in the pharmaceutical industry or medical research or

  • Doctoral degree in Statistics/Biostatistics or other subject with high statistical content
  • Ability to provide sound strategic and statistical input on study/research design to meet project needs, regulatory and scientific requirements
  • Ability in presenting results and defending statistical findings, study design and analysis. This could be to internal audiences (study/product team) or at external meetings such as investigator meetings, steering committee meetings, ad board meetings or regulatory meetings
  • Ability in working within a global team and with CRO partners to ensure operational excellence and efficiencies
  • Demonstrated effective communication skills (written and oral)

  Thrive

  What you can expect of us

  As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

  Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

  • 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 and bi-annual company-wide shutdowns
  • Flexible work models, including remote work arrangements, where possible

  Apply now

  for a career that defies imagination

  Objects in your future are closer than they appear. Join us.

  careers.amgen.com

  Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position

  Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

  We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

  .

  Salary Range

  139,595.00 USD - 170,664.00 USD

• About the company

  Amgen is one of the world’s leading biotechnology companies. Amgen is a values-based company, deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses.

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