Overview
On Site
Full Time
Skills
SAS
Reporting
SDTM
XML
Continuous Improvement
Quality Assurance
Statistics
Data Management
Law
Job Details
Roles & Responsibilities:
- ssist 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.
- 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.
- ccountability 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.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.