PHARMAFull time
Senior Manager - ADaM Standards Lead (Biomedical Data Stewardship)
By Admin · Biostatistics & Statistical Programming
HYDERABAD (IN)ONSITEPOSTED: 10/21/2026
PHARMAFull time
HIRING ORGANIZATIONAMGENBiotechnology / Pharmaceuticals
ROLE OVERVIEW
Amgen seeks a Senior Manager - ADaM Standards Lead for its Biomedical Data Stewardship team in Hyderabad. The role combines ADaM and CDISC standards leadership with people management and cross-functional work across R&D.
ROLE DEFINITION & RESPONSIBILITIES
- •Work with global BMDS leaders and cross-functional partners to keep activities aligned with the enterprise standards strategy.
- •Help develop and maintain data element standards, with emphasis on analysis and reporting standards such as ADaM.
- •Provide subject-matter leadership on adopting and implementing CDISC standards and regulatory guidance documents.
- •Track developments in analysis and reporting standards, CDISC and regulatory guidance or practice.
- •Support process improvement for standards governance and help ensure standards changes are applied consistently and promptly.
- •Manage and develop BMDS staff and resources.
- •Support training, awareness presentations and communications about standards, and provide DES expertise to R&D stakeholders.
- •Build stakeholder relationships and champion efficiency or compliance improvements through technology, including process automation, while following Amgen policies, SOPs and controlled documents.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor's degree or higher in statistics/biostatistics, programming, life science, computer science, business administration, or a related discipline, or an equivalent combination of education and experience
- 6+ years of knowledge or experience in biostatistics or programming in the pharmaceutical/biotech industry
- 4+ years of CDISC ADaM implementation
- People management, including direct reports
PREFERRED QUALIFICATIONS
- •Master's degree or higher in statistics/biostatistics, programming, life science, computer science, business administration, or a related discipline
- •4+ years of experience in a global organization
- •Team and process improvement leadership
- •Effective written and oral communication skills
- •Experience defining, managing, and governing analysis and reporting standards with a focus on ADaM data standards
- •Experience implementing SDTM and ADaM standards across multiple study designs
- •Statistical programming skill for SDTM and ADaM
- •Experience creating SDTM and ADaM submission packages
- •In-depth knowledge of CDISC standards
- •Experience collaborating with global cross-functional teams and influencing decision making
- •Knowledge of project management, documentation writing, training, and compliance
- •Understanding of CDISC Therapeutic Area User Guides (TAUGs)
- •Experience developing and maintaining standards implementation guides
REQUIRED VERIFIED SKILLS
Biostatistics or programming in the pharmaceutical/biotech industry
CDISC ADaM implementation
Clinical Data Interchange Standards Consortium (CDISC) standards
Data element standards (DES)
People management with direct reports
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
Amgen is a company that develops treatments. The posting describes its Biomedical Data Stewardship function as supporting analysis and reporting standards and global clinical development strategy.
TEAM SIZE: 25,000+ employees
INDUSTRY: Biotechnology / Pharmaceuticals
APPLICATION ADVISORY
Highlight your 6+ years of biostatistics or programming experience in pharma/biotech and your 4+ years of CDISC ADaM implementation. Show people-management experience with direct reports, plus any work defining or governing analysis and reporting standards. Mention SDTM/ADaM submission packages, TAUGs or implementation guides if you have them.
SPONSORED · TRAINING
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