Director, Statistical Programming
US - Boston - MA, United States
USD 165K-247K Executive-level Full Time
Tasks
- Collaborate with Biostatistics and Clinical Data Management
- Conduct secondary review of statistical programming deliverables
- Coordinate programming support with clinical operations and pharmacovigilance
- Create programming plans and allocate resources
- Develop validate programming specifications for SDTM and ADaM
- Develop validate protocol specific efficacy outputs
- Ensure SOP compliance
- Ensure audit readiness of study documentation
- Ensure compliance with CDISC and 21CFR Part 11 standards
- Generate analysis datasets
- Generate analysis listings tables and figures
- Identify training needs
- Maintain programming infrastructure
- Manage Statistical Programming team
- Manage budgets and financial forecasting
- Manage vendor governance and contracting
- Oversee statistical programming activities for clinical studies
- Provide line management and mentoring
- Support eCTD submission file preparation
Perks/Benefits
Skills/Tech-stack
21CFR Part 11 | CDISC ADaM | CDISC SDTM | Clinical Trial Data | Clinical trial | ECTD | Financial Management | Part 11 | People management | Process Improvement | Project Management | Project Planning | Relational databases | Resource Management | Resource allocation | SAS | Scope management | Statistical programming | Trial data
Education
Regions
Countries
States
Cities
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