Amgen

Biostatistics Mgr

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Jun 19, 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