Principal Statistical Programmer FSP
Tasks
- Collaborate with internal and external teams ensure project timelines
- Create maintain validate programming standards and macros
- Deliver high-quality statistical programming results validate maintain SAS R programs
- Develop CRFs, edit check specifications, data validation plans
- Develop SAS programs generate datasets listings tables graphs
- Follow FDA regulations for clinical trial data reporting
- Generate SDTM ADaM specifications datasets reviewer’s guide define.xml files
- Oversee CRO’s statistical programming deliverables ensure quality and timelines
- Review and author SOPs and work instructions
- Review author data transfer specifications external data
- Support preparation of clinical study reports regulatory submissions publications
Perks/Benefits
Skills/Tech-stack
CDISC standards | Clinical trial | Clinical trial methodologies | Data Management | FDA Regulations | Programming validation | R | Regulatory Submission | Regulatory submission support | SAS | Submission support | Team Collaboration
Education
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