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Biostatistics Mgr Thousand Oaks United States,  


Posted on : 01 May 2017

Project Description

The Biostatistic Manager will provide statistical contributions, statistical review and quality control of Study Outlines, protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph (TLG) shells, analysis data specifications, other key-study related documentation, protocol deviations, Data Quality Review (DQR), Flash Memos, Clinical Study Reports (CSRs), clinical publications, and other communications.Contribute the exploratory analyses of existing databases in support of the publications and commercialization of existing Amgen productsWork with the statistical programmers to complete statistical analysis of individual studies/projects/publicationsPublish applied research in scientific journals and books, and give presentations on statistical methodology within Amgen and/or in the biopharmaceutical setting at external scientific meetingsBe familiar with statistical policy and strategy at Amgen and assist in the review Amgen Policies, SOPs and other controlled documentsContribute to process improvement and good practices initiativesCommunicate the role of the Global Biostatistics department, and may contribute to statistical training within Global Biostatistics and within Amgen Basic QualificationsDoctoral degree in Statistics/Biostatistics or other subject with high statistical contentORCurrently enrolled in PhD program in Statistics/Biostatistics or other subject matter with high statistical content, and must complete all requirements necessary to obtain Doctoral Degree in the PhD program prior to employment start dateORMasters degree in Statistics/Biostatistics or other subject with high statistical content, and 3 years of directly related statistics experience Preferred Qualifications:Doctoral degree in Statistics/Biostatistics or other subject with high statistical content, and 1 or 2 years of post graduate statistical experience in the pharmaceutical industry or medical researchMasters degree in Statistics/Biostatistics or other subject with high statistical content, and 4 years of post-graduate statistical experience in the pharmaceutical industry or medical researchDesigning, analyzing and/or reporting clinical trials within Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or AcademiaLife-Cycle Drug Development Experience (Clinical Development and Post-marketing)Leadership of at least 1 study/project with minimal oversightAuthored a clinical trial or observational study protocol, DRT/DMC charter, statistical analysis plan, clinical study report, and/or manuscript of clinical trial or observational study resultsKnowledge of fundamentals of project planningEffective communication of written and oral statistical information and clinical trial or observational study resultsCommunication of statistical information (written and oral)Demonstrated effective communication skills (written and oral)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.

Locations

US, California, Thousand Oaks

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