Director, Statistical Programming
Location: Wilmington, United States
USD 165K-247K Executive-level Full Time
Tasks
- Collaborate with Biostatistics and Clinical Data Management
- Collaborate with pharmacovigilance clinical operations and other functions
- Coordinate preferred vendor governance and contracting
- Create programming plans
- Develop and validate programming specifications for analysis datasets
- Develop and validate programs for analysis datasets
- Develop and validate programs for efficacy tables listings figures graphs
- Develop and validate specifications for efficacy tables listings figures graphs
- Ensure compliance with SOPs
- Ensure study documentation filing for audits
- Lead process review and updates
- Maintain programming infrastructure
- Manage budgets and forecasts
- Manage resource allocation and prioritization
- Manage statistical programming team performance
- Oversee statistical programming for clinical studies
- Provide secondary review of programming deliverables
- Support regulatory submissions in eCTD format
Perks/Benefits
Skills/Tech-stack
21CFR Part 11 | ADaM | Biostatistics | Budget Forecasting | CDISC SDTM | Clinical data | Clinical data management | Data Management | ECTD | Financial Management | Leadership | Part 11 | People management | Process Improvement | Project Management | Relational databases | Resource Management | Resource allocation | SAS | Scope management
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
Regions
Countries
States
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