Sr. Scientist, Statistical Programmer, Submission Data Standards Quality Management (Hybrid)
USD 117K-184K Senior-level Full Time
Tasks
- Coach and consult project teams
- Collaborate with statistical programming and regulatory stakeholders
- Ensure data conformance and traceability
- Oversee submission data standards quality management
- Plan submission data standards deliverables
- Prepare questions for FDA e-data mailboxes
- Prepare study data standards plan
- Provide tools and templates for electronic submissions
- Support preNDA and preBLA meeting preparation
- Up version SDTM datasets
Perks/Benefits
Skills/Tech-stack
ADRG | ADaM | CDISC CDASH | Clinical Trial Data | Clinical data | Clinical data standards | Clinical trial | Controlled Terminologies | Data Modeling | Data Quality | Data Standards | Data quality assurance | DefineXML | ECRF | Electronic submissions | HL7 | IRT | Information Systems | Information systems management | Machine Learning | Microsoft Project | Numerical analysis | Pinnacle 21 | Pinnacle 21 Enterprise | Process compliance | Project Management | Quality Assurance | Regulatory Compliance | SAS | SDLC | SDRG | SDTM | SDTM up versioning | Systems Management | Technical writing | Trial data | Waterfall model
Education
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