Biostatistical Programming Manager
Tasks
- Coordinate data issue resolution
- Coordinate programming scope with statisticians
- Coordinate with other study lead programmers
- Create and maintain programming specifications
- Develop ADaM data
- Develop SDTM data
- Develop lookup tables
- Ensure timelines quality and compliance
- Lead study programming end to end
- Manage computing environment
- Manage programmer work assignments
- Manage programming deliverables
- Provide programming input for clinical study start up
- Provide technical leadership for programming team
- Provide training and guidance to programmers
- Represent GSP at clinical study team
- Set programming strategy
- Support regulatory submissions
Perks/Benefits
- N/A
Skills/Tech-stack
Automation | CDISC ADaM | CDISC SDTM | Clinical Data Interchange Standards | Clinical Data Interchange Standards Consortium | Clinical Trial Operations | Clinical data | Clinical trial | DEFINE | Data Quality | Data Quality Checks | Project Management | Python | Quality checks | R | Regulatory Submissions | SAS | SAS Stat | Trial operations
Education
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