Amgen Biostatistics Manager in Thousand Oaks, California
The successful Biostatistics Manager will ensure all statistical aspects pertaining to clinical activities meet required standards and are statistically correctly. The Biostatistics Manager will influence study design, defending statistical approaches both internally and externally ensuring strict adherence to all Amgen’s Policies, SOPs and other controlled documents.
You will also lead on one complex or multiple less complex studies and projects.
Providing statistical contributions, statistical review and quality control of Key Design Elements (KDE) protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph (TLG) shells, Submission Data File (SDF) specifications, other key-study related documentation, protocol deviations, Flash Memos, Clinical Study Reports (CSRs), clinical publications, and other communications
Completing statistical analysis of individual studies/projects
Publishing applied research in scientific journals and books, and give presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings (biopharmaceutical industry and academic meetings)
Being familiar with statistical policy and strategy at Amgen
Staying abreast of latest developments in the field of statistics in drug development and contribute to scientific advances in the field
Communicating the role of the Global Biostatistics department, and may contribute to statistical training within Global Biostatistics and within Amgen
Assisting in the review of Amgen Policies, SOPs and other controlled documents
Assisting with study and systems audits conducted by Amgen CQA and external bodies
Serving as team member of change / process improvement initiatives”
Doctoral degree in Statistics/Biostatistics or other subject with high statistical content
Currently 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 date
Master's degree in Statistics/Biostatistics or other subject with high statistical content and 3 years of statistics experience
Doctorate in Statistics/Biostatistics with 1 year of post-graduate statistical experience in the pharmaceutical industry or medical research
Excellent computing, modelling and simulation skills using R, SAS, WinBugs, FACTS, etc.
Experience in designing, analyzing and reporting of clinical trials within Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia
Proactive and efficient in learning emerging adaptive designs and building simulation tools for wide use and applications
Knowledge of Bayesian statistics
Extensive knowledge of simulation and modeling techniques
Work well with both statistical colleagues and cross functional teams
Good communication skills (written and oral)
Amgen is one of the world’s largest independent biotechnology companies, with global revenue of $23 billion and nearly 20,000 employees globally. For more than 35 years, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.
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.