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STATISTICAL PROGRAMMING

Generate Analysis Data Sets and translation ready tables, listings and figures for Regulatory Submissions and Publications

Our SAS programmers perform statistical and data programming in addition to providing tables, figures, and listings (TFLs) based on the analyses and format specified in the statistical analysis plan, following either our standards or your specific requirements. Works closely with Biostatistics team to carry out planned analyses which include creation and QC of analysis datasets and tables, listings, and figures (TLFs). Quality control is achieved for analysis datasets, tables, listings, and figures via independent programming according to dataset specifications or the SAP, as appropriate to ensure accurate results are provided to Biostatistics before final statistical review. Prepare analysis results for regulatory submissions using computerized systems.

  • CDISC and ADaM Submission ready Dataset Development

  • Dataset Analysis

  • Tables, Listings and Graphs

  • CRF and Database Structure Review for PK/PD Data

  • CDISC implementation (SDTM and ADaM, Define.xml, annotated CRF)

  • Derived Dataset Generation and Validation

  • Tables, figures, and listings creation and validation

  • Regulatory submissions (Development of integrated ADaM datasets for ISS/ISE analyses, Define.XML)

  • Submission-ready datasets and programs.

  • Mock Dataset Generation Prior to Database Lock

  • Data Integration