About the role
Amgen is expanding its global Biomedical Data Stewardship (BMDS) capabilities, with Amgen India (AIN) playing an increasingly critical role in integrated delivery and functional leadership. As Senior Manager, Biomedical Data Stewardship, you will help advance Amgens analysis and reporting standards by leading India-based execution while partnering closely with global BMDS and cross-functional teams.
You will manage and develop BMDS staff and managing resources, as well as oversee the development, governance, and consistent implementation of analysis and reporting data standards, including ADaM, in support of the Design Innovation function within the Center for Design Analysis. This position combines hands- on technical depth, managerial accountability, and cross-functional collaboration to ensure data standards are fit-for-purpose, inspection-ready, and aligned with Amgens global clinical development strategy.
Responsibilities:
- This role supports global Biomedical Data Stewardship objectives through India-based execution and cross-functional collaboration.
- Collaborate with global BMDS leadership and cross-functional partners to ensure alignment with enterprise standards strategy.
- Support development and maintenance of data element standards (DES) with a focus on analysis and reporting standards including Analysis Data Model (ADaM)
- Provide subject-matter leadership and input into the strategic adoption and implementation of Clinical Data Interchange Standards Consortium (CDISC) standards and regulatory guidance documents
- Stay abreast of latest developments and requirements in the field of analysis and reporting standards, CDISC, and regulatory guidance/practice
- Support process improvement initiatives related to the governance of standards
- Ensure changes to standards are implemented consistently and in a timely manner
- Manage and develop Biomedical Data Stewardship staff and managing resources
- Support development and delivery of training, awareness presentations, and/or communications about standards
- Provide DES expertise to stakeholders across RD ensuring alignment across functions
- Develop and maintain strong working relationships with key stakeholders
- Identify and champion opportunities to improve efficiency and compliance via improved technological solutions, including process automation.
- Adhere to all Amgen Policies, SOPs and other controlled documents when developing, maintaining, and governing data standards
This position is currently located at Amgen India (Hyderabad).
Basic Qualifications
- Bachelors degree or higher in statistics/biostatistics, programming, life science, computer science, business administration, or related discipline, or equivalent combination of education and experience
- 6+ years knowledge/experience in biostatistics or programming in the Pharmaceutical/Biotech industry
- 4+ years of CDISC ADaM implementation
- People management, including direct reports
Preferred Qualifications
- Masters degree or higher in statistics/biostatistics, programming, life science, computer science, business administration, or related discipline
- 4+ years of experience in a global organization
- Team and process improvement leadership
- Demonstrated effective communication skills (written and oral)
Data Standards Technical Expertise
- Experience defining, managing, and governing analysis and reporting standards with a focus on ADaM data standards; aptitude for data standards and data standardization
- Experience implementing SDTM and ADaM standards in a practical setting across multiple study designs
- Statistical Programming skill for SDTM and ADaM
- Experience creating SDTM and ADaM submission packages
- In-depth knowledge of CDISC standards
Collaboration Communication
- Experience working in collaboration with global cross-functional teams with demonstrated effective communication skills (written and oral) and ability to influence decision making
- Knowledge of project management, documentation writing, training, and compliance
Process Governance
- Understanding of CDISC Therapeutic Area User Guides (TAUGs)
- Experience developing and maintaining standards implementation guides
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