- Implements, oversees, and supports standards, technical quality, and consistent approaches in strategy, study design, and statistical analysis.
- Plans and implements 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 or 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 areas as well as cross-functionally.
- Is familiar with statistical policy and strategy at Amgen; has a working knowledge of theoretical and applied statistics, regulatory guidelines, and industry practice on biosimilar development.
- Stays abreast of the 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 communicating 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 operating procedures (SOPs), and other standards applicable to biosimilar development.
- 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 or GED and 12 years of biostatistics experience
- Master's degree in statistics, biostatistics, or another 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 another subject with high statistical content and 5 years of post-graduate statistical experience in the pharmaceutical industry or medical research
- Knowledge or experience of biosimilars development, non-inferiority, or 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 of the design, analysis, and reporting of at least 1 complex or multiple less complex studies or projects within the Pharmaceutical/Biotechnology/Public Health setting in Industry, Government, or Academia
- Demonstrated ability to provide sound strategic and statistical input on study or research design to meet project needs and regulatory and scientific requirements
- Demonstrated ability in communicating results and defending statistical findings, study design, and analysis. This could be to internal audiences (study or product team) or at external meetings such as investigator meetings, steering committee meetings, ad board meetings, or regulatory meetings
- Demonstrated ability to work within a global team and with CRO partners to ensure operational excellence and efficiencies
- Demonstrated effective communication skills (written and oral)
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
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Biostatistics Senior Manager, Biosimilars - Washington, United States - Amgen
Description
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of.
Biostatistics Senior Manager, Biosimilars
Live
What you will do
Let's do this. Let's change the world.
In this vital role, you will independently lead a single large product and/or more complex studies and/or projects, ensure that all statistical aspects of documentation of clinical activities meet required standards and are statistically correct, influence and contribute to the development strategy, and defend statistics.
Responsibilities:
Win
What we expect of you
We are all different, yet we all use our outstanding contributions to serve patients. The Biostatistics Senior Manager we seek is technically adept with these qualifications.
Basic Qualifications:
Preferred Qualifications:
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us
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 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.
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