Director, Statistical Programming
US - Wilmington - DE, United States
USD 165K-247K Executive-level Full Time
Tasks
- Collaborate with biostatistics clinical data management pharmacovigilance and clinical operations
- Collaborate with preferred vendor management for governance and contracting
- Coordinate submission readiness with regulatory standards
- Create submission files for eCTD
- Develop and validate programming specifications
- Develop and validate programs for analysis datasets
- Ensure compliance with SOPs
- Generate analysis datasets
- Generate analysis figures
- Generate analysis listings
- Generate analysis tables
- Lead line management and performance reviews
- Lead process review and compliance updates
- Manage budgets forecasting and strategic planning
- Manage project and programming documentation
- Manage staffing resource allocation
- Manage statistical programming infrastructure
- Oversee statistical programming activities
- Provide guidance mentoring and training plans
- Provide secondary reviews of deliverables
Perks/Benefits
Skills/Tech-stack
21CFR Part 11 | Budget Forecasting | CDISC ADaM | CDISC SDTM | Clinical data | Clinical data standards | Cross-Functional Collaboration | Cross-functional | Data Standards | ECTD | Figures | Financial Management | Functional collaboration | Graphs | Line management | Listings | Part 11 | People management | Process Improvement | Programming specifications | Project Management | Protocol Tables | Relational databases | Resource Management | SAS | SQL | Scope management
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
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