Amgen

Senior Biostatistics Manager

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Oct 10, 2020
Ref
R-96792
Required Education
Bachelors Degree
Position Type
Full time
Amgen's Biosimilar Development Organization has an opportunity for a Senior Biostatistics Manager to independently lead a single large product and/or complex studies/projects. In this role, you will ensure that all statistical aspects of documentation pertaining to clinical activities meet required standards and are statistically correct, influence and contribute to the development strategy and defend statistical approaches. As a Senior Biostatistical Manager, will:
  • Implement, oversee and support standards, technical quality and consistent approaches in strategy, study design and statistical analysis.
  • Plan and execute statistical contributions to 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) and other communications in close partnership with CROs in a full-service CRO model.
  • Provide statistical inputs to clinical publications, Clinical Summary of Safety (CSSs), Clinical Summary of Efficacy (CSEs), Clinical Overviews (COs), and regulatory documents.
  • Oversee statistical work performed by CROs in a full-service CRO model.
  • Perform statistical analysis of multiple studies/projects and subsequent exploratory analyses and makes sound conclusions and recommendations.
  • Represent the Biostatistics function and participate in multidisciplinary project team meetings, collaborating with other functional team members and incorporating knowledge of cross-functional areas to inform and provide sound statistical guidance to teams.
  • Proactively anticipate and communicate resource and quality issues that may impact deliverables or timelines within functional area as well as cross-functionally.
  • Maintain a thorough knowledge of Amgen statistical policy and strategy as well as theoretical and applied statistics, regulatory guidelines and industry practice on biosimilar development.
  • Stay abreast of latest developments in the field of statistics in drug development and contribute to scientific advances by publishing applied research in scientific journals and books and presenting statistical methodology at scientific meetings.
  • Participate in the review and development of CRO Policies, SOPs, other controlled documents, Amgen-CRO process maps and process improvements and operational efficiencies.
  • Adhere to all Amgen Policies, Standard operation procedures (SOPs) and other standards which are applicable to biosimilar development.


Basic Qualifications

Doctorate degree and 2 years of Biostatistics experience
OR
Master's degree and 6 years of Biostatistics experience
OR
Bachelor's degree and 8 years of Biostatistics experience

OR

Associate's degree and 10 years of Biostatistics experience

OR

High school diploma / GED and 12 years of Biostatistics experience

Preferred Qualifications
  • Doctoral degree in Statistics/Biostatistics or other subject with high statistical content and 5 years post-graduate statistical experience in the pharmaceutical industry and/or medical research.
  • OR
  • Master's degree in Statistics/Biostatistics or other subject with high statistical content and 8 years post-graduate statistical experience in the pharmaceutical industry or medical research.
  • Working knowledge of biosimilars development, non-inferiority and equivalence trials.
  • Statistical contributions to regulatory submissions.
  • Experience in statistical methodologies related to adaptive designs (e.g., group sequential design, adaptations to treatment arm selection design, Bayesian adaptive design) and/or combined phase 1/2 or phase 2/3 design.
  • Independent leadership in the design, analysis and reporting of complex or multiple less complex studies/projects within the Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia.
  • Proven ability to provide sound strategic and statistical input on study/research design to meet project needs, regulatory and scientific requirements.
  • Demonstrated ability in presenting results and defending statistical findings, study design and analysis.
  • Experience working within a global team and with CRO partners to ensure operational excellence and efficiencies.
  • Strong written/verbal communication and presentation skills.


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.