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 Bristol Myers Squibb recognizes the importance of balance and flexibility in our work setting 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 Read more Duties Responsibilities Primarily responsible for quality and timely delivery of SDTM artifacts SDTM Specifications datasets define xml SDRG Annotated CRF for BMS studies Serve as Study SDTM Programming lead for all regulatory submissions Expertise in BMS SDTM automation tools macros and using them for SDTM programming Identify any inefficiencies and work with experts in up-versioning enhancing existing tools and macros Thorough knowledge of CDISC standards including CDASH SDTM ADaM and keep abreast of latest updates in the industry Design implement the SDTM specification as per the CDISC SDTM IG and ensure they meet downstream ADaM and Reporting requirements Work with standards team to design mapping algorithms for new items Provide input to the design of the clinical trial database from an SDTM perspective Annotate CRFs and Review annotated CRFs in accordance with BMS guidelines and appropriate metadata to reflect tabulation datasets Maintain high quality of deliverables with validation and resolution of issues surfaced in Pinnacle21 and BMS Quality tools to ensure regulatory compliance Provide common language for repe