Director, Statistical Programming
US - Boston - MA, United States
USD 165K-247K Executive-level Full Time
Tasks
- Collaborate with Biostatistics and Clinical Data Management
- Collaborate with pharmacovigilance and clinical operations
- Collaborate with preferred vendor management
- Develop and validate analysis dataset specifications
- Develop and validate efficacy tables listings figures graphs
- Develop and validate programs for analysis datasets
- Ensure compliance with SOPs and controlled documents
- Identify training needs and optimize staff utilization
- Maintain programming infrastructure
- Manage audit ready study documentation filing
- Manage statistical programming team and external partners
- Oversee statistical programming for clinical studies
- Plan and manage programming resource allocation
- Provide leadership for regulatory submissions
- Provide secondary reviews of statistical programming deliverables
Perks/Benefits
Skills/Tech-stack
21CFR Part 11 | Budget Forecasting | CDISC ADaM | CDISC SDTM | Cross-Functional Collaboration | Cross-functional | ECTD | Financial Management | Functional collaboration | Part 11 | Project Management | Relational databases | Resource Management | SAS | Scope management
Education
Bachelor of Engineering | Bachelor of Science | Master of Arts | Master of Science
Regions
Countries
States
Cities
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