Biostatistics Mgr
Location:
Thousand Oaks , California
Posted:
February 07, 2017
Reference:
R-32971
The Biostatistics Manager is responsible for:
Ensuring all statistical aspects of documentation 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 Study Concept Documents (SCDs), 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, Data Quality Review (DQR), 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
Masters degree in Statistics/Biostatistics or other subject with high statistical content, and 3 years of directly related statistics experience
Preferred Qualifications:
Masters degree in Statistics/Biostatistics or other subject with high statistical content, and 4 years of post-graduate statistical experience in the pharmaceutical industry or medical research
or
Doctoral degree in Statistics/Biostatistics or other subject with high statistical content
Designing, analyzing and/or reporting clinical trials within Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia
Life-Cycle Drug Development Experience (Pre-clinical Development, Clinical Development, or Post-marketing)
Leadership of at least 1 study/project with minimal oversight
Authored a protocol, DRT/DMC, SAP, CSR, or Research Project Plan (RPP)
Fundamentals of Project Planning
Demonstrated effective communication skills (written and oral)"
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.


A little about us:
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