Found Description
Responsibilities:
Conduct a comprehensive review of study documents, including Protocol, CRF, and SAP.
Create and assess statistical programs in SAS and/or R to produce CDISC-compliant SDTM and ADaM datasets.
Execution of validation and quality control procedures for programs, datasets, and statistical reports, ensuring alignment with study requirements.
Development and review CDISC SDTM and ADaM mapping specifications.
Produce and review Tables, Figures, and Listings (TFLs) in accordance with the statistical analysis plan.
Review datasets for any pending compliance issues and meticulously document identified issues.
Generation and review of submission documents like , SDTM annotated CRF, and reviewers guide.
Generation of utility macros and efficient code writing to streamline programming processes.
Communicate effectively within project teams to ensure th...