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Director, Non-Clinical/Research Biostatistics

Company: Amgen
Location: Thousand Oaks
Posted on: March 18, 2020

Job Description:

Amgen is a leading global biotechnology company, with a mission to serve patients around the world. Asa science-based, patient-focused organization, we discover and develop innovative therapies to treatserious illnesses. Our medicines have made a dramatic difference in the lives of millions.Reporting into the Global Biostatistics Sciences organization, the Research Biostatistical Director will be responsible for working with Research leads & Development statisticians to execute preclinical statistical strategy primarily within the Oncology therapeutic area and bridge across other therapeutic areas. Activities will include design and analysis of preclinical/non-clinical experiments/studies as well as the development and implementation of standards and statistical approaches in the Research setting to ensure quality and technical excellence within Research functions and across Research.Responsibilities for the Research Biostatistical Director include:

  • Provide statistical input and ensure statistical standards and best practices for assigned preclinical studies and publications
  • Ensure and facilitates optimal statistical design, analysis, and review for preclinical studies and publications
    • Collaborate and communicate effectively with internal and external stakeholders regarding study-specific findings, analysis, and insights
    • Provide statistical consulting, training, and advice within Research and enhance statistical awareness and understanding within preclinical and non-clinical organizations
    • Develop novel statistical methods and tools to address unmet analysis needs in preclinical and nonclinical research
    • Drive ongoing continuous process and technical improvements for Biostatistics in Research
      • Write, test, validate (as appropriate) and execute software programs to produce analysis datasets and tables, listings, and graphs
      • Develop statistical solutions for repetitive experiments to improve the efficiency and promote best practice
      • Serve as the biostatistical filing/regulatory lead for Preclinical as needed
      • Stay abreast of latest development (regulatory and scientific) in the field of nonclinical and preclinical statistics and ensure the internal practice is current
      • May hire, manage and mentor a small number of statistical staffBasic QualificationsDoctorate degree and 4 years of Statistics/Biostatistics oo Clinical experienceORMaster's degree and 8 years of Statistics/Biostatistics or Clinical experience ORBachelor's degree and 10 years of Statistics/Biostatistics or Clinical experiencePreferred Qualifications
        • PhD in Statistics/Biostatistics
        • Life Cycle Drug Development Experience (Pre-clinical Development, Clinical Development, and Post-marketing)
        • Scientific research/publications in one or more areas of statistical science
        • Exposure to leading statistical activities in the Research area
        • Expertise and proficiency in a high-level statistical analysis environment/software such as SAS or R
        • Familiarity with creation of specifications for statistical analysis
        • Ability to effectively perform complex statistical analyses and related tasks
        • Experience in statistical methodology related to design of preclinical experiments, especially in screening and optimization designs
        • Ability to perform thorough Quality Control of own work and of utilities (such as macros)
        • Demonstrated statistical leadership and contribution to Research and preclinical studies and publications
        • Strong writing skills and an ability to communicate well orally with scientists and lay audiences in the English language
        • Ability to manage self, lead and manage others in the successful and timely completion of all statistical activities for a study or multiple studies from end to end
        • Understanding of drug development process, regulatory and industry trends
        • Strong consulting skillsAmgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. 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. 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 , Director, Non-Clinical/Research Biostatistics, Healthcare , Thousand Oaks, California

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