Senior Manager II, Clinical Data Standards & Reporting Engineer at Bristol-Myers Squibb

Hyderabad, Telangana, India

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Biotechnology, HealthcareIndustries

Requirements

Expertise in BMS standards (e.g., protocol, data collection, SDTM, ADaM, TLFs)
Deep knowledge of CDISC standards (e.g., SDTM, ADaM, CDASH, controlled terminology)
Experience with clinical trial standards implementation end-to-end
Ability to interpret and apply global and TA-specific standards for regulatory compliance
Familiarity with submission packages (e.g., define.xml, aCRF, Reviewer’s Guides)
Expertise in industry standards and participation in industry working groups

Responsibilities

Serve as primary point of contact for study teams on BMS standards usage and development (e.g., Clinical Scientists, DB developers, SDTM/ADaM programmers)
Guide study teams in interpreting and applying end-to-end standards for clinical trials to ensure compliance and alignment
Participate in study team meetings as Standards SME, providing interpretation and rationale
Act as consulting resource for validation of CDISC-compliant submission packages
Coach CROs and vendors on BMS standards and processes
Communicate and reinforce BMS standards to project/study teams for consistency
Process clinical standard change requests, develop recommendations/implementation plans, and manage through governance
Participate in Study/Submission team meetings as applicable
Contribute to/lead development of global and TA-specific standards aligned with CDISC/BMS frameworks
Lead development of new standard forms, data elements, protocol standards, and analysis/reporting standards
Create and maintain global/TA libraries of standard metadata (e.g., protocol, data collection, SDTM, analysis)
Create and maintain global/TA submission standards (e.g., define.xml, aCRF, Reviewer’s Guides)
Support complex implementation scenarios with guidelines and ensure Regulatory/CDISC compliance
Support/lead harmonization efforts across Clinical, Biometrics, Data Management, and Regulatory functions
Participate in development/maintenance of global/TA clinical standards (e.g., CRF/non-CRF CDASH, SDTM mapping, controlled terminology), including documentation
Act as expert on industry standards (e.g., SDTM, ADaM, CDISC controlled terminology)
Participate in industry working groups related to standards
Evaluate and process change requests for new/modified global/TA standards through governance

Skills

Key technologies and capabilities for this role

CDISCSDTMADaMTLFsProtocol StandardsData Collection StandardsClinical Data StandardsRegulatory ComplianceCDISC ValidationStudy Team Support

Questions & Answers

Common questions about this position

What benefits does Bristol Myers Squibb offer?

Bristol Myers Squibb offers a wide variety of competitive benefits, services, and programs that provide employees with resources to pursue their goals both at work and in their personal lives.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What salary can I expect for this Senior Manager role?

This information is not specified in the job description.

What key skills and experience are required for this role?

The role requires expertise as a Standards SME in CDISC standards including SDTM, ADaM, protocol, data collection, and TLFs, along with experience guiding study teams, coaching CROs/vendors, and leading development of global and TA-specific standards.

What is the company culture like at Bristol Myers Squibb?

The culture is challenging, meaningful, and life-changing, with uniquely interesting work, opportunities to grow and thrive alongside high-achieving teams, and a focus on balance and flexibility.

Bristol-Myers Squibb

Develops and delivers biopharmaceutical medicines

About Bristol-Myers Squibb

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.

New York City, New YorkHeadquarters

1887Year Founded

$33,706.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Flexible Work Hours

Hybrid Work Options

Professional Development Budget

Risks

Increased competition in oncology from emerging biotech firms like ArsenalBio.

BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.

Rapid AI and digital tech evolution may pose integration challenges for BMS.

Differentiation

BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.

The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.

BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.

Upsides

BMS's partnership with Medidata enhances clinical research processes and patient outcomes.

The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.

BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.

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