About this role
About the Role Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN) playing a key role in integrated delivery and functional leadership. As Biostatistics Manager, you will provide technical expertise and support the execution of statistical deliverables for clinical studies, ensuring adherence to CfDA and regulatory standards.
What You'll Do
- 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
What We're Looking For
- Strong statistical leadership in clinical trial statistics and the ability to provide technical expertise
- Experience as a GBS lead on the Clinical Study Team and in executing trials per protocol
- Ability to perform risk assessments and ensure data quality and alignment with study objectives
- Experience overseeing KDEs, protocols, randomization specs, SAPs, TFLs, CSRs, and related documentation
- Excellent cross-functional collaboration and stakeholder communication
- Knowledgeable of regulatory standards (CfDA) and current drug development statistics practices
- Proactive in staying up-to-date with statistical developments and contributing to scientific advances
- Experience reviewing external supplier deliverables for quality and driving process improvements
- Strong self-management and resource management capabilities
- Familiarity with TMF maintenance and controlled documents
Nice to Have
- Knowledge of innovative trial design and latest developments in statistics in drug development
- Familiarity with Amgen policies, SOPs, and other controlled documents
- Experience coordinating with external suppliers and ensuring quality deliverables