Amgen

Biostatisticis Mgr

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Aug 09, 2019
Ref
R-72023
Required Education
Masters Degree/MBA
Position Type
Full time
The Biostatistics Mgr

• Ensuring all statistical aspects pertaining to clinical activities meet required standards, quality and technical excellence

• Provide statistical input to design, conduct, analysis, interpretation and reporting of clinical studies

• Effectively communicating statistical concepts and methods and promoting novel statistical approaches

• Adhering to all Amgen Policies, SOPs and other controlled documents

Key activities include:

• 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

Basic Qualifications:

Doctoral degree in Statistics/Biostatistics or other subject with high statistical content

OR

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

OR

Master's degree in Statistics/Biostatistics or other subject with high statistical content and 3 years of statistics experience

Preferred Qualifications:

Doctorate degree in statistics or biostatistics

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.

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.

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.