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For your reference, we have included the original job posting below.
Biostatistics Manager Hematology / Oncology
Job Number:
44736712
Company Name:
Amgen
Job Location:
South San Francisco, CA US
Job Categories:
Clerical & Administrative Research
Biostatistics Manager Hematology / Oncology
The Biostatistics Manager role can be based either at Amgen's headquarters in Thousand Oaks, CA or at Amgen's South San Francisco site.
In this role, the Biostatistics Manager will:
• Provide 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 • Complete statistical analysis of individual studies/projects • Publish 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) • Be familiar with statistical policy and strategy at Amgen • Stay abreast of latest developments in the field of statistics in drug development and contribute to scientific advances in the field • Communicate the role of the Global Biostatistics department, and may contribute to statistical training within Global Biostatistics and within Amgen • Assist in the review of Amgen Policies, SOPs and other controlled documents • Assist with study and systems audits conducted by Amgen CQA and external bodies • 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 • Doctoral degree in Statistics/Biostatistics or other subject with high statistical content or • 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
• Designing, analysing 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 experience delivering effective communication of written and oral statistical information
