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Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN) playing a key role in integrated delivery and functional leadership. The Director, Design & Innovation provides strategic, operational, and people leadership for Design & Innovation capabilities based in Amgen India. This role is accountable for building, managing, and scaling India-based teams across Biomedical Data Stewardship (BMDS), Centralized Statistical Monitoring (CSM), Safety Statistics (SS), and Global Randomization & Blinding (GRB).
Job Responsibility:
Provides leadership for Design & Innovation functions based in India, ensuring delivery of high-quality, compliant, and value-added outputs aligned with global standards and strategy
Serves as the primary people leader and managerial owner for India-based staff across BMDS, CSM, SS, and GRB
Acts as a strategic partner to global Design & Innovation leaders, supporting execution of the global vision while representing India capabilities, capacity, and growth opportunities
Drives adoption of innovative design, statistical, data stewardship, centralized statistical monitoring, safety monitoring, and randomization/blinding approaches in collaboration with global function heads
Ensures consistent application of Amgen policies, SOPs, and controlled documents across all India-based Design & Innovation activities
Supports capability development, talent pipeline growth, and succession planning for Design & Innovation functions in India
Provides oversight of resourcing, prioritization, and workload balancing across India-based teams
Translate global Design & Innovation strategy into executable plans for India-based teams
Support delivery of innovative statistical methodologies, data standards, centralized statistical monitoring, safety monitoring, and randomization/blinding services
Partner with global leaders to identify opportunities for expanding Design & Innovation capabilities and scope at AIN
Ensure operational excellence, quality, and regulatory compliance across all supported functions
Recruit, develop, coach, and retain high-performing Design & Innovation staff in India
Build a strong leadership bench across BMDS, CSM, SS, and GRB in alignment with future-state organizational needs
Foster a collaborative, inclusive, and high-accountability culture consistent with Amgen values
Oversee performance management, development planning, and career progression for direct reports
Act as the primary liaison between India-based Design & Innovation and CfDA teams and global counterparts
Collaborate with Development Therapeutic Areas, Global Biostatistics, Global Patient Safety, Dev IS, CfOR, PMED, and other partners as needed
Support global and local AIN initiatives related to innovation, process improvement, technology adoption, and standards implementation
Ensure adherence to regulatory expectations, internal controls, and quality standards
Support development, review, and implementation of policies, SOPs, and standards relevant to Design & Innovation activities
Participate in audits, inspections, and quality reviews as required
Requirements:
Master’s degree or higher in Statistics, Biostatistics, Computer Science, Mathematics, Life Sciences, or related scientific discipline
At least 8 years of experience in the pharmaceutical, biotechnology, or medical research industry
Demonstrated experience in people management, including direct reports
Strong written and verbal English communication skills
Experience working effectively in a globally distributed, cross-cultural environment
Nice to have:
Doctorate degree in Statistics, Biostatistics, or related field
Experience across one or more of the following domains: statistical innovation, data stewardship, safety statistics, centralized statistical monitoring, or randomization and blinding
Working knowledge of drug development across multiple phases
Experience with regulatory submissions and interactions
Demonstrated success leading multidisciplinary teams in a matrixed organization
Experience driving innovation, process improvement, or capability build-out
Experience developing or implementing policies, SOPs, and standards
Budget, resource planning, and vendor oversight experience
External visibility through industry groups, forums, or professional organizations
What we offer:
Vast opportunities to learn and develop within our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits