Amgen

Biostatistics Manager (clinical studies hematology/oncology)

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Oct 06, 2020
Ref
R-102358
Required Education
Bachelors Degree
Position Type
Full time
The Biostatistics Manager provides statistical leadership for clinical studies in hematology/oncology.

The Biostatistics Manager 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.

Responsibilities:
  • 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 Amgen's 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.


Basic Qualifications:

Doctorate degree

OR

Master's degree and 3 years Statistics/Biostatistics experience

OR

Bachelor's degree and 5 years Statistics/Biostatistics experience

OR

Associate's 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

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Join Us

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.