Director, Statistical Programming
US - Boston - MA, United States
USD 165K-247K Executive-level Full Time
Tasks
- Allocate resources and prioritize work
- Collaborate with biostatistics clinical data management pharmacovigilance and clinical operations
- Conduct performance reviews and mentoring
- Conduct secondary reviews of statistical programming deliverables
- Coordinate with preferred vendor management
- Create and review programming plans
- Develop and validate analysis dataset specifications
- Develop and validate protocol efficacy table listing figure and graph specifications
- Ensure compliance with SOPs
- Ensure compliance with functional guidelines policies and SOPs
- Ensure study documentation filing for audit readiness
- Forecast and manage department budget
- Generate analysis data listings tables and figures
- Generate analysis datasets
- Maintain programming infrastructure
- Manage Statistical Programming team
- Manage adherence to company policies SOPs and controlled documents
- Oversee statistical programming activities for clinical studies
- Support eCTD submission package creation
Perks/Benefits
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | Budget Forecasting | CDISC ADaM | CDISC SDTM | CFR Part 11 | Clinical data | Clinical data standards | Data Listings | Data Standards | Data Submission Preparation | Data submission | ECTD | Figures | Financial Management | Graphs | Part 11 | Process Improvement | Program specifications | Project Planning | Relational databases | Resource Management | SAS | Scope management | Submission preparation | Tables
Education
N/A
Regions
Countries
States
Cities
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