Amgen

Biostatistics Manager

Employer
Amgen
Location
Thousand Oaks, CA
Posted
Jun 17, 2021
Ref
R-121074
Required Education
Bachelors Degree
Position Type
Full time

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Biostatistics Manager

Live

What you will do

Lets do this. Lets change the world. In this vital role you will ensure all statistical aspects pertaining to clinical activities meet required standards and are statistically accurate.

  • Providing Statistical support for a late-stage product team. The position will involve both study-level and product level support including but not limited to serving as the study statistician for on-going clinical trial or observational studies, participation in regulatory and routine safety submission activities. (Such as statistical support for coordinated analyses or responses to regulatory questions and support for safety reporting activities).
  • The incumbent will have very good communication (written, verbal and presentation) and team interaction skills.
  • Provide statistical contributions, statistical review and quality control of Study Outlines (SO), 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 under the general oversight of a Study Lead Statistician or Global Statistical Lead
  • Work with statistical programmers to 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

Win

What we expect of you

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

Basic Qualifications

Doctorate degree

Or

Masters degree and 4 years of Statistics/Biostatistics or other subject with high statistical content experience

OR

Bachelors degree and 6 years of Statistics/Biostatistics or other subject with high statistical content experience

Preferred Qualifications
  • Doctoral degree in Statistics/Biostatistics or other subject with high statistical content. 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
  • 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, analyzing and/or reporting clinical trials within Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia
  • Life-Cycle Drug Development Experience (Clinical Development and Post-marketing)
  • Leadership of at least 1 study/project with minimal oversight
  • Authored a clinical trial or observational study protocol, DRT/DMC charter, statistical analysis plan, clinical study report, and/or manuscript of clinical trial or observational study results
  • Knowledge of fundamentals of project planning
  • Effective communication of written and oral statistical information and clinical trial or observational study results

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.

  • Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
  • A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
Apply now for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.


Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.