Sr. Scientist, Statistical Programmer, Submission Data Standards Quality Management (Hybrid)
USD 117K-184K Senior-level Full Time
Tasks
- Attend regulatory agency meetings
- Coach and consult project teams
- Contribute to continuous improvement of electronic submission process
- Create Define xml SDRG and ADRG deliverables
- Develop tools and templates for electronic submissions
- Ensure data traceability quality assurance and data conformance
- Guide teams for submission deliverables
- Manage up versioning of SDTM
- Oversee submission data standards quality management
- Plan submission data standards activities
- Prepare questions for FDA e-data mailboxes
- Prepare study data standards plan
Perks/Benefits
- 401k
- Annual bonus
- Dental insurance
- Hybrid work arrangement
- Long-term incentive plan
- Medical insurance
- Paid Holidays
- Paid sick days
- Retirement benefits
- Vacation days
- Visa sponsorship
- Vision insurance
Skills/Tech-stack
ADRG | ADaM | CDASH | Central Lab Data | Clinical data | Clinical data standards | Controlled Terminologies | Data Fitness | Data Modeling | Data Quality | Data Standards | Data conformance | Data quality assurance | Data traceability | Define.xml | ECRF | Electronic submissions | HL7 | IRT | Information Management | Lab data | Machine Learning | Metadata Management | Microsoft Project | Pinnacle 21 | Pinnacle 21 Enterprise | Process compliance | Project Management | Python | Quality Assurance | R | Regulatory Compliance | S&OP | SAS | SDLC | SDRG | SDTM | Statistical programming | Technical writing | Waterfall model
Education
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