ClinChoice
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Pharmaceutical
Develop and validate SDTM and ADaM datasets using R per CDISC standards, support TLF generation in R or SAS, perform QC and reconciliation, collaborate with biostatistics and clinical teams, contribute to automation, documentation, and version control for regulatory-compliant clinical trial deliverables.
Pharmaceutical
Lead statistical activities for oncology clinical trials, providing strategic input, developing analysis plans, and mentoring junior statisticians. Collaborate on regulatory submissions and ensure compliance with standards.
Pharmaceutical
Lead end-to-end statistical programming for oncology clinical trials: develop and validate SDTM/ADaM datasets, produce TLFs, support integrated analyses (ISS/ISE), manage study timelines and vendors, and prepare submission-ready outputs (define.xml, annotated CRFs, reviewer guides) for regulatory submissions (FDA/EMA/PMDA).
