Director, Statistical Programming
US - Wilmington - DE, United States
USD 165K-247K Executive-level Full Time
Tasks
- Collaborate with biostatistics clinical data management and other functions
- Coordinate with preferred vendor management
- Create files for electronic submission
- Develop and validate SAS programs
- Develop and validate programming specifications
- Ensure adherence to company policies and controlled documents
- Ensure compliance with SOPs
- Forecast and manage department budget
- Generate analysis datasets
- Generate efficacy tables listings figures and graphs
- Lead statistical programming team
- Maintain programming infrastructure
- Manage contract budgets for external providers
- Manage programming documentation for audits
- Oversee statistical programming activities
- Perform secondary reviews of deliverables
- Plan and manage resource allocation
Perks/Benefits
Skills/Tech-stack
21CFR Part 11 | ADaM | Budget Forecasting | CDISC ADaM | CDISC SDTM | Clinical Data Interchange Standards | Clinical Data Interchange Standards Consortium | Clinical Trial Data | Clinical data | Clinical trial | Data specification | ECTD | Financial Management | Governance | Mentoring | Part 11 | Programming Infrastructure | Project Management | Project Planning | Relational databases | Resource Management | SAS | SDTM | SOP compliance | Scope management | Trial data
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
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