Job Title: Senior Manager II – Clinical Data Standards & Reporting Engineer
Location: Hyderabad, Telangana, India
Job Type: Full-Time
Company Overview:
Bristol Myers Squibb (BMS) is a global biopharmaceutical leader committed to transforming patients’ lives through science. At BMS, employees engage in uniquely impactful work that spans clinical development, cell therapy breakthroughs, and data-driven innovation. We foster a culture of collaboration, inclusion, and scientific excellence, providing opportunities for career growth while advancing healthcare globally.
Role Overview:
BMS is seeking a Senior Manager II, Clinical Data Standards & Reporting Engineer to lead the development, implementation, and governance of clinical data standards and reporting frameworks. This role ensures compliance with regulatory requirements and industry standards, supports study teams across multiple therapeutic areas, and drives the adoption of CDISC-aligned clinical data standards for global and TA-specific studies.
Key Responsibilities:
Study and Project Support:
Serve as the primary point of contact for study teams on the application and interpretation of BMS clinical data standards.
Guide teams on standards implementation across protocol, data collection, SDTM, ADaM, and TLFs.
Act as a Standards SME in study team meetings and provide consultation on CDISC-compliant submission packages.
Coach CROs and vendors on BMS standards and related processes.
Process and implement clinical standard change requests through the governance framework.
Global & Therapeutic Area Standards Development:
Lead the creation and maintenance of global and TA-specific standards libraries, including protocol, data collection, SDTM, and analysis standards.
Develop new standard forms, protocol standards, and reporting guidelines across studies.
Support harmonization efforts across Clinical, Biometrics, Data Management, and Regulatory functions.
Participate in industry working groups and maintain expertise in CDISC standards (SDTM, ADaM, CDASH, controlled terminology).
Governance & Process Management:
Evaluate, process, and implement change requests for clinical data standards.
Develop SOPs, guidance documents, and training materials for standards implementation.
Provide oversight of standards governance committees and ensure timely documentation and compliance.
Identify process improvement opportunities and share best practices with study teams and departments.
Tools & Systems Expertise:
Serve as a technical SME for Medidata Rave (EDC), Metadata Repositories (MDR), SDTM validation platforms (e.g., Pinnacle 21), and SAS/R coding systems.
Develop, maintain, and innovate clinical data transformation tools, including macros and programs.
Support adoption of new technologies for clinical data standards management.
Qualifications & Experience Required:
Education: Bachelor’s degree in life sciences, computer science, or related field; advanced degrees preferred.
Experience: 12–15 years in clinical trials with a focus on clinical data standards.
Strong expertise in CDISC standards (CDASH, SDTM, ADaM) and global clinical data reporting.
Experience with Medidata Rave, Metadata Repositories, SDTM programming, and define.xml requirements.
Deep understanding of Health Authority regulations, regulatory compliance, and pharmaceutical development processes.
Demonstrated ability to communicate complex data standards and solutions to cross-functional teams.
Experience in CRF design, query resolution, data validation, and reporting standards.
Why Join BMS:
Engage in life-changing work that impacts patients globally.
Collaborate with high-achieving teams across clinical, biometrics, data management, and regulatory functions.
Drive innovation and adoption of global clinical data standards in a supportive and inclusive environment.
Access opportunities for career growth, learning, and leadership in clinical data management and reporting.
Equal Opportunity & Accessibility:
BMS is committed to inclusion, diversity, and accessibility. We provide reasonable accommodations for candidates with disabilities and ensure equal employment opportunities for all qualified applicants.
Application Process:
Submit your resume online via our careers portal. BMS will never request payments, financial information, or social security numbers during recruitment.
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