Sr. Manager, SDTM Implementation, Statistical Programming

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Position Summary

This position provides expertise to drive excellence and consistency in statistical programming SDTM implementation team.  Primarily, this position is responsible for providing strategic oversight to project deliverables and related technologies that support analysis and reporting activities.  This person will provide technical expertise, as required, to development teams and serve as a point of escalation for issues unable to be resolved at the team level. 

Position 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 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 expertise/support

Key Competency Requirements

• BA/BS degree or equivalent in a relevant scientific discipline with a minimum of 7 plus years of experience supporting clinical trials for regulatory submissions
• Experience as a Lead Programmer overseeing SDTM activities of support programmers as well as CRO/external vendors
• Train junior programmers on company standards and processes. Serve as a point of escalation for issues that cannot be resolved by support Programmers.
• Expert experience with CDSIC standards including CDASH or SDTM/ADaM.
• Thorough understanding of MDR concepts and ability to interact with Standards Governance bodies to impart compound specific knowledge for change requests.
• Hands on experience using SDTM validator tools such as  Pinnacle21. Identify common issues, diagnose the root cause and provide standard language for submissions package.
• Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate data formats
• Demonstrates ex