Provide statistical contributions, review, and quality control of study design documents, including Key Design Elements (KDE) and protocols
Serve as the GBS lead on the Clinical Study Team leadership team, ensuring quality data collection and alignment between data collection and study objectives
Oversee statistical contributions to key design elements, protocols, statistical analysis plans, and other study-related documentation
Collaborate cross-functionally to deliver robust analysis results in Table, Figure and Listings (TFLs), Clinical Study Reports (CSRs), and other communications
Communicate effectively with internal and external stakeholders regarding study-specific findings and insights
Stay updated on the latest statistical developments in drug development and contribute to scientific advances in the field
Assist in the review of Amgen Policies, SOPs, and other controlled documents
Contribute to process improvement initiatives and operational efficiencies
Manage self and other resources according to priorities
Assist with the development and implementation of technology utilizing AI to streamline statisticians' work
Qualification Required:
MSc or PhD in Statistics, Biostatistics, or related field
Approximately 3-5 years of relevant industry experience
Proven ability to apply statistical methods in clinical development
Doctorate degree in Statistics/Biostatistics (preferred)
Experience in machine learning, real-world data analytics, and other related applications (preferred)
Life-cycle drug development experience (preferred)
Experience working effectively in a globally dispersed team environment (preferred)
Key Responsibilities:
Provide statistical contributions, review, and quality control of study design documents, including Key Design Elements (KDE) and protocols
Serve as the GBS lead on the Clinical Study Team leadership team, ensuring quality data collection and alignment between data collection and study objectives
Oversee statistical contributions to key design elements, protocols, statistical analysis plans, and other study-related documentation
Collaborate cross-functionally to deliver robust analysis results in Table, Figure and Listings (TFLs), Clinical Study Reports (CSRs), and other communications
Communicate effectively with internal and external stakeholders regarding study-specific findings and insights
Stay updated on the latest statistical developments in drug development and contribute to scientific advances in the field
Assist in the review of Amgen Policies, SOPs, and other controlled documents
Contribute to process improvement initiatives and operational efficiencies
Manage self and other resources according to priorities
Assist with the development and implementation of technology utilizing AI to streamline statisticians' work
Qualification Required:
MSc or PhD in Statistics, Biostatistics, or related field
Approximately 3-5 years of relevant industry experience
Proven ability to apply statistical methods in clinical development
Doctorate degree in Statistics/Biostatistics (preferred)
Experience in machine learning, real-world data analytics, and other related applications (preferred)
Life-cycle drug development experience (preferred)
Experience working effectively in a globally dispersed team environment (preferred)
