Biostatistics Sr Mgr

2 months ago

Washington DC, United States Amgen Full time
Job DescriptionHOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

Biostatistics Senior Manager

Live

What you will do

Lets do this. Lets change the world. In this vital role you will achieve results through detailed goal setting, accountability measures, effective partnership, performance management, collaboration with other groups and a dedication to serving customers, both inside and outside of, Global Study Operations (GSO).

The Senior Biostatistics Manager independently leads sophisticated studies and projects in the oncology therapeutic area, 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 through participating in and collaborating with multidisciplinary project teams. Specific duties include:

  • 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 oncology drug development.
  • Staying current in developments in the field of statistics in drug development (innovative trial design) and Amgens statistical policies, procedures and strategies.
  • Contributing to process improvements and operational efficiencies.Win

    What we expect of you

    We are all different, yet we all use our unique contributions to serve patients. The Biostatistical professional we seek is an emerging leader with these qualifications.

    Basic Qualifications

  • Doctorate degree and 2 years of experience or
Masters degree and 4 years of experience ORBachelors degree and 6 years ofexperience ORAssociates degree and 10 years ofexperience ORHigh school diploma / GED and 12 years of experience

Preferred Qualifications

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 oncology drug development.Proven in leadership and motivating multi-functional team to advance complex projects to completion and thoughtfully negotiate and influenceStrong verbal and written communication combined with organizational skills and cross-cultural sensitivityStatistical 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.

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 planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply 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.

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