Job Description

• 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.

• 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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