Sr. Manager, SDTM Implementation, Statistical Programming

Bristol-Myers Squibb - Remote, OR

Full-time - Mid Level

Remote - Remote, OR

Chemical Manufacturing

About the position

This position at Bristol Myers Squibb focuses on providing expertise in statistical programming, specifically in the implementation of SDTM (Study Data Tabulation Model). The role involves strategic oversight of project deliverables and technologies that support analysis and reporting activities, ensuring quality and timely delivery of SDTM artifacts for regulatory submissions. The individual will also provide technical support to development teams and act as a point of escalation for unresolved issues.

Responsibilities

• 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.
• Utilize BMS SDTM automation tools and macros for SDTM programming, identifying inefficiencies and enhancing existing tools.
• Maintain thorough knowledge of CDISC standards including CDASH/SDTM/ADaM and stay updated on industry changes.
• Design and implement SDTM specifications according to CDISC SDTM IG, ensuring they meet downstream ADaM and Reporting requirements.
• Provide input on the design of clinical trial databases from an SDTM perspective.
• Annotate and review CRFs in accordance with BMS guidelines and appropriate metadata.
• Ensure high quality of deliverables through validation and resolution of issues in Pinnacle21 and BMS Quality tools.
• Provide common language for unresolved validation issues across projects for inclusion in SDRG.
• Collaborate with stakeholders and study team members to manage timelines and resolve issues.
• Represent SDTM Programming in study team meetings and cross-functional groups.
• Support automation and innovation for process enhancements to improve quality and efficiency.
• Oversee CRO/vendor programming activities to ensure adherence to standards and timely deliverables.
• Participate in study/project team meetings as a core member, providing technical expertise.

Requirements

• BA/BS degree or equivalent in a relevant scientific discipline.
• Minimum of 7 years of experience supporting clinical trials for regulatory submissions.
• Experience as a Lead Programmer overseeing SDTM activities of support programmers and CRO/external vendors.
• Expertise in CDISC standards including CDASH, SDTM, and ADaM.
• Thorough understanding of MDR concepts and interaction with Standards Governance bodies.
• Hands-on experience with SDTM validator tools such as Pinnacle21.
• Understanding of clinical data structures and relational database structures.
• Expertise in handling and processing upstream data from multiple sources.
• Proficient in programming languages, especially SAS for producing SDTM datasets.
• In-depth knowledge of FDA/ICH guidelines and good programming practices.
• Excellent communication, planning, project management, and vendor management skills.

Benefits

• Competitive salary
• Comprehensive health insurance
• 401(k) retirement plan
• Flexible work arrangements
• Professional development opportunities
• Employee wellness programs