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 to execute clinical trials according to the protocol, performing risk assessments and ensuring quality data collection and alignment between data collection and study objectives
Oversee statistical contributions to key design elements, protocols, randomization specifications, statistical analysis plans, tables, figures and listing shells, submission data file specifications, and other key study-related documentation
Collaborate cross-functionally to deliver robust, valid and scientifically rigorous analysis results in Table, Figure and Listings (TFLs), Flash Memos (FM), Clinical Study Reports (CSRs), clinical publications, and other communications
Ensure statistics sections of the TMF are maintained and up-to-date
Communicate effectively with internal and external stakeholders regarding study-specific findings, analysis,
and insights
Contributes to defining signal detection threshold
Manages self and collaborates closely with peers to ensure timely and quality deliverables
Reviews deliverables from external suppliers for quality
Staying abreast of the latest developments in the field of statistics in drug development and contribute to scientific advances in the field
Assisting in the review of Amgen Policies, SOPs, and other controlled documents
Contributing to process improvement initiatives and operational efficiencies.
Manage self and other resources according to priorities
Knowledgeable of developments in the field of statistics in drug development (creative trial design) and Amgens statistical policies, procedures and strategies.
Assist with the development and implementation of technology that utilizes AI to streamline statisticians' work.