The Senior Study Data Tabulation Model (SDTM) Statistical Programmer, provides oversight and creation of the SDTM
deliverables for analysis and reporting and world-wide regulatory application submissions of drug and vaccine clinical
development projects. Accountability predominantly includes creation and validation of study data standard deliverables (SDTM
dataset, Define.XML, SDRG, aCRF), collaborating with project teams, outreach to external vendors and partners, and keeping
current with industry submission data standards.
The incumbent will be responsible for continuous improvement of our electronic submission process for study data standards
deliverables and providing tools and templates to assist delivery focusing on traceability, quality assurance, data conformance
and data fitness. The position is a key collaborator with statistical programming, statistics, global data management and other
project stakeholders. New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully
vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement,
subject to applicable law.
Primary Responsibilities:
• Assist project teams in creating SDTM deliverables for Analysis and Reporting
(A&R) and submission.
• Support project teams in preparing submission deliverables including use of
Pinnacle 21 Enterprise.
• Up-versioning activities to specific versions of SDTM.
• Partner effectively with project team members.
• Participation in industry teams and conferences on best practices.
• Membership on departmental strategic initiative project teams.
