Responsibilities:
Review and ensure accurate and high-quality statistical programming deliverables from CRO.
Perform generation, validation and QC/QA of SDTM, ADaM and TFL output in accordance with SOPs, SOIs, and guidance documents.
Create and maintain specifications as per SDTM/ADaM standard and study SAP.
Define and create ad-hoc reports and listings for clinical teams.
Develop, implement and maintain SAS programming standards.
Builds/tests programs for Data Validation, Derivation, and Data Reports to identify inconsistencies and support data review efforts, as necessary.
Verifies completeness of relevant study deliverables prior to release from the group Maintains all required study documentation.
Consults and provides input into system validation efforts including tool maintenance activities.
Ensure CRF meets the guidelines of the protocol and check for consistency and adequacy.
Work in tandem with Biostatistics and Data Management member on various clinical projects.
Review CRF annotations and data specifications.
Perform quality control on final reports.
Develop SAS coding and table templates for preparing, processing and analyzing clinical data.
Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues.
Perform clinical study report and/or exploratory analysis for oncology clinical study
Perform validation of ADaM datasets and TLFs per SAP.
Effectively review and comment on vendor programming deliverables and help resolve technical difficulties.
Requirements:
BS or above in computer science/statistics with at least 5 years of SAS experience in major pharma or CRO.
Develop SAS coding for generating SDTM, ADaM datasets and TLFs to support clinical study analysis
Proficient computer skills across multiple applications and OS environments
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