Senior Biostatistics Manager
- Employer
- Amgen
- Location
- Working from home
- Start date
- Nov 30, 2021
View more
- Discipline
- Science/R&D, Biostatistics
- Required Education
- High School or equivalent
- Position Type
- Full time
Job Details
- Implement, supervise 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.
- Anticipate and communicate resource and quality issues that may impact deliverables or timelines within functional area as well as cross-functionally.
- Maintain a detailed 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 communicating 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.
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 Masters 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.
- 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.
- 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.
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Company
We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.
We live the mission.
We win together.
We thrive on continual challenge.
Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.
At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.
Connect with us to explore how you can Win, Live, and Thrive at Amgen.
- Website
- http://careers.amgen.com/
- Phone
- 805-447-1000
- Location
-
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
Get job alerts
Create a job alert and receive personalized job recommendations straight to your inbox.
Create alert