Senior Manager, Clinical Data Standards

Working with Us

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Duties

• Lead the development and maintenance of global clinical data standards, ensuring alignment with industry frameworks such as the Clinical Data Interchange Standards Consortium (CDISC), Study Data Tabulation Model (SDTM), and controlled terminology.
  • Oversee the creation of metadata, mappings between operational and SDTM standards, and documentation of standard usage.
  • Serve as a subject matter expert in study and project team meetings, providing input on Case Report Form (CRF) design, CRF Completion Guidelines, programmed edit checks, data transfer specifications, SDTM mapping specifications, and annotated CRFs.
  • Act as a consulting resource for project teams on operational data standards, SDTM, Analysis Data Model (ADaM), and CDISC controlled terminology.
  • Support the validation of SDTM domains, leveraging industry-standard tools and custom validation programs to ensure data integrity and compliance.

Requirements

• Employer will accept a Bachelor’s degree or foreign equivalent degree in Bioinformatics, Microbiology, or a related field and seven (7) years of post-bachelor, progressive, work experience as a Clinical Data Manager or related occupation.
• Must have seven (7) years of experience with/in the pharmaceutical development process; Creating data mapping specifications utilizing industry standards, including Clinical Data Interchange Standards Consortium (CDISC), Clinical Data Acquisition Standards Harmonization (CDASH), Study Data Tabulation Models (SDTM), or Analysis Data Models (ADaM); Medidata Rave and Metadata Repository; Interpreting and complying with Health Authority regulations; Submission requirements, including annotated Case Report Forms, XPT files, and define.xml.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

Work-life Benefits

• Paid Time Off: US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People With Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.