Role Overview
Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN) playing a pivotal 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 junior staff, and ensure the delivery of high-quality statistical outputs meeting CfDA and global regulatory expectations.
Core Responsibilities
Statistical Guidance & Leadership: Utilize deep expertise to provide sound statistical guidance across clinical development, reimbursement, and medical affairs.
Study Execution & Reporting: Plan and execute statistical contributions to clinical protocols, Flash Memos (FM), and Clinical Study Reports (CSRs).
Deliverable Governance: Oversee statistical contributions to key design elements, randomization specifications, Statistical Analysis Plans (SAP), Table, Figure, and Listing (TFL) shells, submission data file specifications, and related documentation.
Study Team Leadership: Serve as the Global Biostatistical Sciences (GBS) lead on the Clinical Study Team leadership team, executing clinical trials according to protocol, conducting risk assessments, and ensuring alignment between data collection and study objectives.
Vendor & FSP Management: Oversee Functional Service Provider (FSP) statisticians and external contractors, rigorously reviewing their contributions for quality and adherence to standards.
Trial Master File Compliance: Ensure statistics sections of the Trial Master File (TMF) are maintained, compliant, and up-to-date.
Technical & Domain Standards
Methodological Innovation: Promote, implement, and communicate innovative and standard statistical methodologies, trial designs (e.g., innovative trial designs), and advanced data analysis strategies.
Regulatory & Publication Support: Contribute directly to clinical publications, regulatory filing dossiers, reimbursement submissions, and high-impact scientific communications.
Technology & AI Enablement: Lead technology adoption and leverage AI capabilities to streamline biostatistical workflows and drive operational efficiencies.
Benefits & Total Rewards
Comprehensive Total Rewards Plan comprising health, finance, and wealth planning benefits.
Work-life balance programs and career development opportunities within a diverse global biotechnology leader.
