Senior Biostatistics Manager
HOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing and delivering ever-better products that read over 10 million patients worldwide. Its time for a career you can be proud of. Join us.LiveWhat you will doAmgens 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 accurate, influence and contribute to the development strategy and defend statistical approaches. As a Senior Biostatistical Manager, will:
- 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.
- 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