Senior Manager II – Clinical Data Standards & Reporting Engineer
Location: Hyderabad, India
Company: Bristol Myers Squibb (BMS)
Job Type: Full-Time
About the Role
Bristol Myers Squibb (BMS) is seeking an experienced Senior Manager II, Clinical Data Standards & Reporting Engineer to lead the development, implementation, and governance of global clinical data standards. This role supports clinical trials across therapeutic areas by ensuring regulatory compliance, CDISC alignment, and consistent data quality across the lifecycle of clinical studies.
This is an excellent opportunity for senior professionals with deep experience in clinical data standards, CDISC frameworks, and clinical data management systems.
Key Responsibilities
Study and Project Support
Serve as the primary subject matter expert for BMS standard applications across protocol development, data collection, SDTM, ADaM, and TLF standards.
Support study teams by interpreting and implementing end-to-end clinical standards across global and therapeutic areas.
Participate in study team meetings and provide guidance on CDISC-compliant submission packages.
Coach CROs and external vendors on BMS standards and technical processes.
Review and manage standards-related change requests and ensure governance framework compliance.
Global & Therapeutic Area Standards Development
Lead and contribute to the development of global and TA-specific standards.
Develop and maintain metadata libraries including protocol standards, CDASH, SDTM, ADaM, and reporting standards.
Support the creation of submission deliverables including define.xml, aCRF, and Reviewer’s Guides.
Ensure alignment with regulatory guidelines, CDISC models, and internal frameworks.
Participate in industry working groups and represent BMS in standards-related initiatives.
Governance and Process Management
Manage global standards governance, including change request evaluation and approval processes.
Support SOPs, job aids, and training documentation for standards implementation.
Act as liaison between governance committees and cross-functional teams.
Lead strategic process improvements and harmonization initiatives across Clinical, Data Management, Biometrics, and Regulatory functions.
Tools & Systems Expertise
Serve as technical expert for Medidata Rave, Metadata Repositories (MDR), SDTM validation tools (e.g., Pinnacle 21), SAS, and R.
Develop and maintain clinical data transformation tools, macros, and mapping specifications.
Support implementation of new technologies and tools for metadata management and standards automation.
Required Qualifications
Education
Bachelor’s degree required (Life Sciences, Data Science, Statistics, Computer Science, or related field preferred).
Experience (Mandatory)
12 to 15 years of industry experience in clinical trials, with significant focus on clinical data standards.
Strong understanding of CDISC standards including USDM, CDASH, SDTM, ADaM, and controlled terminology.
Experience with EDC systems (preferably Medidata Rave) and Metadata Repositories.
In-depth knowledge of the pharmaceutical development process.
Experience in CRF design, mapping specifications, data validation, and define.xml requirements.
Strong compliance background with the ability to interpret Health Authority regulations.
Skills
Proficiency in SAS or R programming.
Excellent communication and cross-functional leadership skills.
Ability to manage complex standards governance processes.
Strong organizational, analytical, and problem-solving capabilities.
Why Join Bristol Myers Squibb
BMS offers a collaborative environment where scientific innovation meets purpose. Employees are empowered to grow through industry-leading opportunities, global exposure, and meaningful contributions to patient-focused research.
Benefits include:
Competitive compensation and benefits
Work flexibility based on role designation (site-essential, hybrid, remote-by-design)
Support for employees with disabilities
Career progression across global functions
Application & Candidate Information
BMS complies with global equal employment regulations and does not request payment, financial details, or sensitive personal information during recruitment. For additional information on EEO, accessibility, and data protection, refer to the official BMS Career site.
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