Amgen Biostatistics Manager in Thousand Oaks, California

The Biostatistics Mgr will ensure all statistical aspects pertaining to clinical activities meet required standards and are statistically correct

Influencing study design, and defending statistical approaches internally and externally

Leading one complex or multiple less complex studies/projects

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

Serving as team member of change / process improvement initiatives"

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 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.