Job Description

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Employer:       Bristol-Myers Squibb Company

Position:         Senior Manager, Clinical Data Standards (Ref: 2096)

Location:        3551 Lawrenceville Road, Princeton, NJ 08540

Duties:  Utilize experience with Clinical Data Interchange Standards Consortium (CDISC), data base design, Metadata Repository (MDR), and Medidata Rave (EDC) to lead in the development and maintenance of global clinical data standards, including operational CDISC Study Data Tabulation Model (SDTM), controlled terminology, non-CRF (case report form) standard data mappings and other applicable industry standards.  Participate in relevant study and project team meetings as standards SME (subject matter expert) and provide input for standards components, such as CRF design, CRF Completion Guidelines, programmed edit checks, data transfer specifications, SDTM mapping specifications and SDTM annotated CRF. Act as SME on operational data standards, SDTM and/or Analysis Data Model (ADaM) standards, and CDISC controlled terminology.  Act as a consulting resource for project teams regarding the validation of SDTM domains, which may include output from industry standard software tools and BMS custom validation programs. Work with standards management systems and software in the development of systems and processes for creation and maintenance of data standards, including specifications, mappings between standards, and checking adherence to these data standards.  Coach CROs (Contract Research Organization) and vendors on BMS data standards and related processes. Communicate and reinforce content and interpretation of BMS data standards to project and study teams, to ensure consistency in understanding and implementation of standards across a project. Process clinical data change requests for new or existing metadata, including developing a Standards manager recommendation and implementation plan for the standard, as applicable, and ensuring that the request is processed through the appropriate levels of the CDSGO (Clinical Data Standards Governance Organization). Lead, facilitate and participate in the committees of the CDSGO, partner with functional area stewards, organizing standards topics to be reviewed and ensuring decisions are made in a timely manner, documented in meeting minutes and other forms, and implemented. Provide input and information to facilitate key discussions and decisions regarding standards use and implementation. Provide guidance to Study Teams and Submission Teams on SDTM standards and related submission requirements. Lead and participate in the development of CDS (Clinical Data Standards) or cross functional SOPs (Standard Operating Procedure), Working Procedures, Guidance documents, and job aids. Lead and participate in the identification, review, evaluation, and implementation of new technologies related to data standards.  Develop training materials and provide training on CDS-developed processes. Provide mentoring, coaching and escalation support to more junior personnel or contract staff, as required. Lead and participate in strategic initiatives, special projects, and working groups contributing to business decisions and process changes. Identify and propose process improvements while maintaining a strategic focus. Share new industry standards, best practices with project and study teams, and within department as required. May telecommute from any US location.

Requirements: Master’s degree in Chemistry or a related field plus 5 years of post-baccalaureate experience showing demonstrable ability in the skills set described above. Alternatively, employer will accept a Bachelor’s degree in Chemistry or a related field plus 7 years of post-baccalaureate experience showing demonstrable ability in the skills set described above.

** This position is eligible for our employee referral program

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.