Amgen

Biostatistics Manager

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Jul 14, 2019
Ref
R-74846
Required Education
Masters Degree/MBA
Position Type
Full time
Amgen is seeking a Biostatistics Manager at our global headquarters in Thousand Oaks, CA to report into the Director of Biostatistics.

The Biostatistics Manager will provide statistical support for a late stage product team and 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 periodical safety submission activities (such as statistical support for integrated analyses or responses to regulatory questions and support for safety reporting activities).

Key responsibilities of the Biostatistics Manager include:

  • Provides statistical contributions, statistical review and quality control of Study Outlines (SO), protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Figures, Listing (TFL) shells, 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
  • Works with statistical programmers to complete statistical analysis of individual studies/projects
  • Publishes 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)
  • Provides basic knowledge on drug development and be familiar with related agency guidelines
  • Stays abreast of latest developments in the field of statistics in drug development and contribute to scientific advances in the field
  • Preferred to know about innovative statistical methods including Bayesian adaptive methods and have good programming skills using SAS, R and/or other statistical software
  • Communicates the role of the Global Biostatistics department, and 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


Basic Qualifications:

Doctoral degree in Statistics/Biostatistics and/or other subject with high statistical content
OR
Currently enrolled in PhD program in Statistics/Biostatistics and/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

OR

Master's degree in Statistics/Biostatistics and 3 years of directly related statistics experience

Preferred Qualifications:
  • Doctoral degree in Statistics/Biostatistics or other subject with high statistical content or
    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
  • Strong communication and team interactions skills


Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.