SAS Programmer-III Job at cGxPServe, Cambridge, MA

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  • cGxPServe
  • Cambridge, MA

Job Description

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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