Role Overview
Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN) playing a key role in integrated delivery and functional leadership. As a Biostatistics Senior Manager, you will lead study-level statistical deliverables with substantial independence, manage small teams, mentor staff, and ensure high-quality statistical outputs that align with CfDA and international regulatory requirements.
Core Responsibilities
Statistical Strategy & Guidance: Provide sound statistical guidance to teams across clinical development, medical affairs, and reimbursement.
Study-Level Deliverables: Plan, author, and execute statistical sections of clinical study protocols, Statistical Analysis Plans (SAPs), Flash Memos, and Clinical Study Reports (CSRs).
Deliverable Specifications: Oversee statistical contributions to key study design elements, randomization specifications, Table, Figure, and Listing (TFL) shells, and submission data file specifications.
Study Team Leadership: Act as the Global Biostatistical Sciences (GBS) lead on the Clinical Study Team leadership team, executing clinical trials in alignment with protocol requirements, conducting risk assessments, and ensuring rigorous data collection quality.
Vendor & FSP Oversight: Supervise Functional Service Provider (FSP) statisticians and external contractors, conducting thorough quality checks on their deliverables.
TMF Compliance: Ensure all biostatistical documentation and sections in the Trial Master File (TMF) are kept accurate and up to date.
Technical & Domain Standards
Methodological Innovation: Implement, promote, and evaluate innovative and standard statistical methodologies, advanced trial designs (including adaptive and innovative designs), and modern data analysis approaches.
Regulatory Submissions: Deliver robust, scientifically sound analysis results for regulatory filings, reimbursement dossiers, and high-impact clinical publications.
AI & Technology Transformation: Champion technology adoption, leveraging artificial intelligence (AI) tools and automation to streamline statistical workflows and enhance operational efficiency.
Benefits & Total Rewards
Generous Total Rewards Plan encompassing health, finance, wealth planning, work-life balance, and career growth benefits.
Inclusive global biotechnology community offering extensive learning and international leadership pathways.
