The Senior Manager of Biostatistics in Biosimilar Development independently leads a single large product, and/or more complex studies and/or projects, ensures that all statistical aspects of documentation pertaining to clinical activities meet required standards and are statistically correct, influences and contributes to the development strategy, and defends statistical approaches internally and externally.
- Implements, oversees and supports standards, technical quality and consistent approaches in strategy, study design and statistical analysis.
- Plans and executes 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.
- Provides statistical inputs to clinical publications, Clinical Summary of Safety (CSSs), Clinical Summary of Efficacy (CSEs), Clinical Overviews (COs), and regulatory documents.
- Oversees statistical work performed by CROs in a full-service CRO model.
- Performs statistical analysis of multiple studies/projects and subsequent exploratory analyses, and makes sound conclusions and recommendations.
- Represents the Biostatistics function and participates in multidisciplinary project team meetings; collaborates closely with other functional team members; incorporates knowledge of cross-functional areas to inform and provide sound statistical guidance to teams (e.g. provides support and input in case report form design, and data collection).
- Proactively anticipates and communicates resource and quality issues that may impact deliverables or timelines within functional area as well as cross-functionally.
- Be familiar with statistical policy and strategy at Amgen; having working knowledge of theoretical and applied statistics and of regulatory guidelines and industry practice on biosimilar development.
- Stays abreast of latest developments in the field of statistics in drug development and contributes to scientific advances by publishing applied research in scientific journals and books and presenting statistical methodology at internal or external scientific meetings.
- Participates in the review of CRO Policies, SOPs and other controlled document development, and in the development and review of Amgen-CRO’s process maps; contributes to process improvement and operational efficiency.
- Adheres to all Amgen Policies, Standard operation procedures (SOPs) and other standards which are applicable to biosimilar development.
Doctorate degree and 2 years of Biostatistics experience
Master’s degree and 6 years of Biostatistics experience
Bachelor’s degree and 8 years of Biostatistics experience
- Masters degree in Statistics/Biostatistics or other subject with high statistical content, and 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research
- Doctoral degree in Statistics/Biostatistics or other subject with high statistical content, and 5 years of post-graduate statistical experience in the pharmaceutical industry or medical research
- Knowledge/experience of biosimilars development, non-inferiority or equivalence trials
- Statistical contributions to regulatorysubmissions
- Experience in the utilization of Bayesian statistics in clinical trials
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.