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Senior Biostatistics Manager - Oncology

Company: Amgen
Location: Thousand Oaks
Posted on: March 24, 2020

Job Description:

Amgen has a long-term commitment to patients through developing a new class of novel molecules - and we are looking for the talent to ensure these molecules become medicines and realize their potential for helping patients. Amgen's Department of Global Biostatistical Science (GBS) is at the core of this commitment through introducing innovative study design and data analysis. The oncology therapeutic area in GBS has an opportunity for an experienced biostatistician to join our dynamic team and contribute to Amgen's commitment to patients worldwide.The Senior Biostatistics Manager independently leads complex 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 contribute 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, pediatric filing, marketing support 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.
  • Overseeing 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 deliverables or timelines.
  • Working knowledge of regulatory guidelines in oncology 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.Basic Qualifications Doctorate degree and 2 years of Biostatistics experienceORMaster's degree and 6 years of Biostatistics experienceORBachelor's degree and 8 years of Biostatistics experienceORAssociate's degree and 10 years of Biostatistics experienceORHigh school diploma / GED and 12 years of Biostatistics experiencePreferred Qualifications
    • Doctorate degree in biostatics or statistics.
    • 5 or more years pharma/biotech statistical experience.
    • Life cycle drug development experience (pre-clinical, clinical and post-marketing).
    • Experience with oncology drug development.
    • Proven project leadership experience.
    • Strong communication and organizational skills.
    • 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.Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Keywords: Amgen, Thousand Oaks , Senior Biostatistics Manager - Oncology, Executive , Thousand Oaks, California

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