Biostatistics Manager - Oncology
US - California - Thousand Oaks - Field/Remote
Career Category
ClinicalJob Description
HOW MIGHT YOU DEFY IMAGINATION?
Youâve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youâve worked hard to acquire and the passion you already have. At Amgen, our shared missionâto serve patientsâdrives all that we do. It is key to our becoming one of the worldâs leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Biostatistics Manager - Oncology
Live
What you will do
Letâs do this. Letâs change the world. In this vital role you will leads projects and studies, ensuring all statistical aspects pertaining to clinical activities meet required standards and are statistically correct while influencing study design, defending statistical approaches and adhering to Amgen Policies, SOPs and other controlled documents.
- Provide 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, key-study related documentation, protocol deviations, Flash Memos, Clinical Study Reports (CSRs), clinical publications and other communications.
- Complete statistical analysis of individual studies/projects.
- Publish applied research in scientific journals and books, making presentations on statistical methodology in the biopharmaceutical setting at external scientific functions such as biopharmaceutical industry and academic meetings.
- Keep full knowledge of Amgenâs statistical policies and strategies.
- Stay abreast of the latest developments in the field of statistics in drug development and contributing to scientific advances in the field.
- Communicate the role of the Global Biostatistics department within the company and contributing to statistical training.
- Assist in the reviews of Amgen Policies, SOPs, controlled documents and study and systems audits conducted by Amgen CQA and external bodies.
- Serve as team member of change / process improvement initiatives.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a go-getter with these qualifications.
Basic Qualifications:
- Doctorate degree OR
- Masterâs degree and 3 years Statistics/Biostatistics experience OR
- Bachelorâs degree and 5 years Statistics/Biostatistics experience OR
- Associateâs degree and 10 years Statistics/Biostatistics research experience Or
- High school diploma / GED and 12 years of Statistics/Biostatistics experience
Preferred Qualifications:
- Doctoral degree in Statistics/Biostatistics or other subject with high statistical content
Thrive
What you can expect of us
As we work to develop treatments that take care âŚ
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Annual bonus program Career development Career development opportunities Comprehensive employee benefits Comprehensive employee benefits package Financial plans Flexible Spending Accounts Flexible work models Health and welfare plans Life and Disability insurance Professional and personal growth Remote work Retirement and Savings Plan Retirement savings plan Stock-based long-term incentives Time-off plans Total Rewards Plan Welfare plans Work-life balance
Tasks- Process Improvement
- Publish research
- Study design
- Training
Biostatistics Biotechnology Clinical Research Clinical Study Reports Communications Data analysis Drug Development Oncology Process Improvement Publications Quality Control Research Sales SOPS Statistical analysis Statistical analysis plans Statistical Methodology Statistics Study Design Training
Experience10 years 12 years 3 years 5 years
EducationAssociate Associates Bachelor's DO Doctorate Doctorate degree GED High School High school diploma Master's Statistics
TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9