Biostatistics Senior Manager (open to Remote)
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.
What you will do
Amgens Biosimilar Development Organization has an opportunity for a Biostatistics Senior 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.
What we expect of you
Doctorate degree and 2 years of Biostatistics experience OR Masters degree and 6 years of Biostatistics experience OR Bachelors degree and 8 years of Biostatistics experience OR Associates degree and 10 years of Biostatistics experience OR High school diploma / GED and 12 years of Biostatistics experience.
- 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.
- 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.
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
- 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
Apply now for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation. #GDO2021
Join UsIf 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.