Associate Director, Statistical Programming
Tasks
- Allocate resources across programs
- Coordinate internal and external programmers
- Develop and review TFL shells SDTM and ADaM specifications
- Develop global tools reusable macros and utilities
- Develop review TFL SDTM and ADaM specifications
- Develop scientific documentation with biostatisticians
- Ensure defensively program verification of results
- Ensure timely quality development validation of statistical programming deliverables
- Identify programming issues and implement improvements
- Independently develop SAS programs and specifications
- Lead statistical programming for clinical trials
- Manage CROs and contractors for compliance quality and timelines
- Manage statistical computing environment
- Oversee study level programming deliverable timelines
- Recruit mentor and develop statistical programmers
- Represent statistical programming in audits inspections and health authority meetings
- Serve as lead programmer to produce and validate tables listings figures and analysis datasets
- Write programming specifications for regulatory publication and ad hoc analyses
Perks/Benefits
Skills/Tech-stack
ADaM | Analysis Plan | Base SAS | CDISC | Data Management | Data Management Plan | Define.xml | ECTD | EMA | FDA | GCP | ICH | R | SAS | SAS Macro | SAS Stat | SDTM | Spotfire | Statistical Analysis | Statistical Analysis Plan
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
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