Biostatistics Mgr

Career Category
Research Job Description
Join Amgen ’s Mission of Serving Patients

At Amgen , if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. 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.
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.
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, proficient in advanced R programming

- 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 degreeOR

- Master’s degree and 3 years ofStatistics/BiostatisticsexperienceOR

- Bachelor’s degree and 5 years ofStatistics/Biostatisticsexperience.

Preferred Qualifications:
- Doctorate degree in statistics or biostatistics

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and