Director, Design & Innovation (Biostatistics)
ROLE OVERVIEW
Amgen is expanding its global Biostatistics organization, positioning Amgen India (AIN) as a critical hub for integrated clinical development delivery. This Director, Design & Innovation role offers a rare opportunity to build and lead India-based teams across Biomedical Data Stewardship, Centralized Statistical Monitoring, Safety Statistics, and Global Randomization & Blinding. As the primary India interface to global Design & Innovation leaders, you will shape capability growth, operational excellence, and innovation adoption while ensuring regulatory compliance and high-quality statistical outputs. The position combines strategic leadership, people management, and cross-functional influence, making it ideal for an experienced biostatistics professional eager to drive tech-enabled transformation in a globally distributed pharma environment. You will help scale AIN’s footprint and influence the future of clinical trial design and data science at Amgen.
ROLE DEFINITION & RESPONSIBILITIES
- •Translate global Design & Innovation strategy into executable India-based plans across BMDS, CSM, Safety Statistics, and GRB, ensuring alignment with therapeutic area and enterprise priorities.
- •Build, manage, and scale high-performing India teams, overseeing recruitment, workload balancing, career development, succession planning, and performance management.
- •Serve as primary India liaison to global Biostatistics, Patient Safety, Development IS, and CfDA leaders, driving cross-functional collaboration and transparent communication.
- •Champion adoption of innovative statistical methods, centralized monitoring, data stewardship standards, and randomization/blinding approaches with global function heads.
- •Ensure compliance with Amgen SOPs, regulatory expectations, and quality standards; support audits, inspections, and corrective actions across Design & Innovation activities.
- •Drive capability growth by identifying expansion opportunities, implementing policies and standards, and supporting technology adoption and process improvement initiatives.
- •Provide oversight of resourcing, prioritization, vendor partners, and budgets to deliver high-quality, timely outputs that support global drug development programs.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Master’s degree or higher in Statistics, Biostatistics, Computer Science, Mathematics, Life Sciences, or related scientific discipline.
- Minimum 8 years of experience in the pharmaceutical, biotechnology, or medical research industry.
- Demonstrated people management experience with direct reports, including coaching, development, and performance oversight.
- Strong written and verbal English communication skills for global, cross-cultural collaboration.
- Experience working effectively in globally distributed, matrixed environments with cross-functional stakeholders.
- Proven ability to translate strategy into operational plans and ensure regulatory compliance across clinical statistics functions.
- Working knowledge of drug development phases, regulatory submissions, and clinical data standards.
PREFERRED QUALIFICATIONS
- •Doctorate in Statistics, Biostatistics, or related field.
- •Experience across statistical innovation, data stewardship, safety statistics, centralized monitoring, or randomization/blinding.
- •Working knowledge of multiple drug development phases and regulatory submissions.
- •Budget, resource planning, and vendor oversight experience.
- •External visibility through industry groups, forums, or professional organizations.
REQUIRED VERIFIED SKILLS
COMPENSATION & REWARDS
ORGANIZATION CONTEXT & CULTURE
Amgen is a leading global biopharmaceutical company committed to unlocking the potential of biology for patients suffering from serious illnesses. It discovers, develops, manufactures, and delivers innovative human therapeutics, focusing on areas with high unmet medical needs such as oncology, cardiovascular disease, bone disease, and inflammatory diseases.
EXPECTED CAREER ROADMAP
APPLICATION ADVISORY
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