Senior Principal Biostatistician providing statistical expertise across therapeutic areas in clinical development. Collaborating with study teams and overseeing analysis plans for vital projects.
About the role
- Clinical Scientist Director supporting late-phase clinical development and overseeing clinical trials at Amgen. Collaborating with cross-functional teams to ensure regulatory compliance and data integrity.
Responsibilities
- Support late-phase clinical development by translating scientific and clinical strategy into actionable execution across clinical trials.
- Serve as a clinical and scientific subject-matter expert for the assigned therapeutic area and disease indication, focusing on protocol execution and data integrity.
- Work cross functionally to ensure clinical strategy is translated into the development of study documents.
- Provide guidance and assistance in managing collaborators, consultants, and/or Clinical Research Organizations (CROs).
- Review and analyze clinical trial data for accuracy, completeness, and adherence to protocol and regulatory requirements.
- Ensure integrity of protocols for final governance approval.
- Conduct thorough data quality assessments to maintain high standards of data accuracy and integrity throughout the trial lifecycle.
Requirements
- Doctorate degree and 4 years of life sciences/healthcare experience OR Master’s degree and 7 years of life sciences/healthcare experience OR Bachelor’s degree and 9 years of life sciences/healthcare experience.
- 5 years of pharmaceutical clinical drug development experience.
- Strong preference for individuals with proven track record of clinical trial process improvement.
- Industry or academic experience in late-phase drug development for Inflammation Development Therapeutic Area.
- Strong communication & presentation skills in English to clearly communicate scientific concepts/data to leadership committees both internally or externally (both written and oral).
- Experience with designing, monitoring, and implementing clinical trials for the Inflammation Development Therapeutic Area and interpreting test results in compliance with Good Clinical Practice standards and regulatory requirements.
- Understanding of conducting study data readout activities, including data cleaning, database lock, data extract, producing outputs of data.
- Experience drafting high level submission documents for regulatory submissions including authoring clinical regulatory responses for health regulatory interactions.
- Serving as a contributing author to scientific publications and data presentations at scientific conferences.
- Experience in clinical data analysis such as Spotfire or other data analysis tools.
Benefits
- Vast opportunities to learn, develop, and move up and across our global organization.
- Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act.
- Generous AMGEN Total Rewards Plan comprising healthcare, finance, wealth, and career benefits.
- Flexible work arrangements.
Job title
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