Biostatistics Senior Manager
Location: Thousand Oaks, California
Posted: August 13, 2016
Reference ID: 746944554
Will represent Biostatistics on operational and strategic study or project teams. May work on integrated analyses used in regulatory or reimbursement submissions. May serve as statistical project lead responsible for achieving study-related Biostatistical milestones and deliverables and managing external team members. May represent Biostatistics in meetings with regulatory agencies and may prepare written or oral responses to regulatory agency questions. May provide statistical input in the development of manuscripts and other publications. May interact with members of the Global Safety organization on annual safety documents.
Doctorate degree and 2 years of Clinical experience
Master's degree and 6 years of Clinical experience
Bachelor's degree and 8 years of Clinical experience
Associate's degree and 10 years of Clinical experience
High school diploma / GED and 12 years of Clinical experience
Understanding of regulatory guidelines (FDA, EMA) related to the design, analysis and reporting of clinical trials; experience working on global regulatory submissions; experience related to the design, analysis and reporting of prospective or retrospective studies; 4 years of experience in the biopharmaceutical industry.
Experience and fluency in SAS and/or R Strong written, oral and presentation skills including the ability to present quantitative results to non-quantitative audiences
Solid leadership experience
Project management experience
If 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.
Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.