Biostatistics Mgr

Amgen • Thousand Oaks, CA

3d • $131,552 - $177,982

About The Position

Join Amgen’s Mission of Serving Patients. Amgen is a global biotechnology company with a mission to serve patients living with serious illnesses. Since 1980, Amgen has been a pioneer in biotech, focusing on four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease. The company is advancing a pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity. As a member of the Amgen team, you will help make a lasting impact on patients' lives by researching, manufacturing, and delivering innovative medicines. Amgen offers a collaborative, innovative, and science-based culture. The Biostatistics Manager role is vital for leading sophisticated studies in General Medicine therapeutic areas (Cardiometabolic, Inflammation, Nephrology, and Neuroscience), ensuring statistical aspects of clinical activities meet required standards. This role involves influencing strategy development, defending statistical approaches, and representing Global Biostatistical Science (GBS) on 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.
• Proficient with advanced R programming.

Nice To Haves

• Doctorate degree in statistics or biostatistics.

Responsibilities

• 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.
• Influences and supplies to strategy development.
• Defends statistical approaches.
• Represents GBS through participating in and collaborating with multidisciplinary study teams.
• Provides 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.
• Completes statistical analysis of individual studies/projects, proficient in advanced R programming.
• Publishes applied research in scientific journals and books, and gives presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings (biopharmaceutical industry and academic meetings).
• Stays abreast of the latest developments in the field of statistics in drug development and contributes to scientific advances in the field.
• Communicates the role of the Global Biostatistics department.
• May contribute to statistical training within Global Biostatistics and within Amgen.
• Assists in the review of Amgen Policies, SOPs, and other controlled documents.
• Assists with study and systems audits conducted by Amgen CQA and external bodies.
• Serves as a 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