Senior Statistical Programmer Consultant (Oncology) Remote
Tasks
- Act as programming lead manage timelines deliverables
- Coordinate with biostatistics data management medical writing regulatory affairs
- Develop validate maintain ADaM datasets
- Develop validate maintain SDTM datasets
- Ensure programming meets FDA EMA PMDA requirements
- Lead oncology programming activities
- Oversee CRO and vendor programming compliance quality
- Perform complex data derivations and analyses
- Prepare define xml annotated CRFs reviewer guides
- Prepare submission ready programming outputs and documentation
- Produce TLF for study reporting
- Respond to regulatory queries and data requests
- Review ensure traceability consistency quality
- Support integrated analyses ISS ISE
Perks/Benefits
Skills/Tech-stack
ADaM | CDISC | EMA | FDA | ISE | ISS | PMDA | R | SAS | SDTM
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
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