Biostatistics Manager

　　WHAT YOU WILL DO

　　Let’s do this. Let’s change the world. In this vital role you will achieve results through detailed goal setting, accountability measures, effective partnership, performance management, collaboration with other groups and a dedication to serving customers, both inside and outside of, CfDA (Center for Design & Analysis). The Biostatistics Manager independently leads sophisticated studies in the General Medicine therapeutic areas (Cardiometabolic, Inflammation, Nephrology, and Neuroscience), ensuring that the statistical aspects of clinical activities meet required standards and are robust and valid. Will also influence and supply to strategy development, defend statistical approaches and represent GBS (Global Biostatical Science) through participating in and collaborating with multidisciplinary study teams.

　　WIN

　　WHAT WE EXPECT OF YOU

　　We are all different, yet we all use our outstanding contributions to serve patients. The professional we seek is proficient with these qualifications.

　　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 the 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:

　　Doctorate degree OR Master’s degree and 3 years of experience OR

　　Bachelor’s degree and 5 years of experience OR Associate’s degree and 10 years of experience OR High school diploma / GED and 12 years of experience

　　PREFERRED QUALIFICATIONS:

　　Doctorate degree in statistics or biostatistics