Amgen Inc. seeks a Biostatistics Manager in Thousand Oaks, CA.
Work You’ll Do
Provide statistical contributions, statistical review and quality control of protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph (TLG) shells, Submission Data File (SDF) specifications, other key-study related documentation, Flash Memos, Clinical Study Reports (CSRs), clinical protocol deviations, publications and other communication. Apply statistical methods and work with statistical programs, such as R and SAS, to complete statistical analysis of individual studies and projects. Publish applied research in scientific journals and books, and give presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings. Contribute to the exploratory analyses of existing databases to support publications and the commercialization of existing products. Use development software, including C++, Python and R, to develop statistical modeling and reduce computation time. Stay abreast of the latest developments in the field of statistics in drug development and contribute to scientific advances in the field. Communicate the role of the Global Biostatistics department, and contribute to statistical training within the organization. Assist with the review of statistical policies, SOPs and other controlled documentation. Play a key role in process improvement and good practice initiatives.
Doctorate degree in Biostatistics, Statistics or related field or Master's degree in Biostatistics, Statistics or related field and 3 years of directly related experience. Must have statistics experience in clinical research field.
Must have experience in the following:
Using statistical software, including R, SAS and STATA, to complete statistical analysis and conduct simulation studies for statistical methodology research projects;
Explaining statistics to non-statisticians;
Authoring statistical analysis plans and statistical reports for pharmaceutical or public health areas; and
Publishing applied research papers in medical and public health area.
Any suitable combination of education, training or experience is acceptable.
Full time employment, Monday – Friday, 40 hours per week.
TO APPLY: Please mail resume to Tania Horst, HR Operations Manager, 2202 N. Westshore Blvd., Suite 250, Tampa, FL 33607, and refer to Requisition Code # AMCA0008.