Bristol Myers Squibb - Senior Manager - SAS / SDTM

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 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. Read more :

• 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 repeated unresolvable validation issues across projects within a compound for inclusion in SDRG.
• Collaborate with stakeholders and Study team members to manage study timelines and resolve issues.
• Represent SDTM Programming function in Study team meetings as well as cross-functional working groups.
• Support and identify areas for automation & innovation as process enhancements to improve quality of work and efficiencies.
• Provide oversight of CRO / vendor programming activities to ensure adherence of standards as well as receiving quality and timely deliverables.
• Participate in study / project team meetings as a core member and provide technical :
• BA / BS in a relevant scientific discipline with more than 8 plus years Pharmaceutical / CRO experience as a SAS Programmer supporting clinical trials for regulatory submissions with expertise in CDSIC / SDTM.
• Significant knowledge of SAS software and general computing as relates to clinical drug development.
• Knowledge of the drug development process, clinical trial methodology, CDISC Standards and familiarity with global regulatory requirements.
• Ability to work successfully within cross-functional teams leading to successful global regulatory filings and approvals.
• Ability to be flexible and adapt quickly to the changing needs of the organization.
• Ability to organize multiple work assignments and establish priorities.

(ref : hirist.tech)