Biostatistics Manager, General Medicine (U.S. - Remote)

Amgen • Thousand Oaks, CA

2d • Remote

About The Position

Join Amgen’s Mission of Serving Patients. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

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.

Requirements

• Doctorate degree OR Master’s degree and 3 years of Statistics/Biostatistics experience OR Bachelor’s degree and 5 years of Statistics/Biostatistics experience.

Nice To Haves

• Doctorate degree in statistics or biostatistics

Responsibilities

• 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

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager