Sr. Statistical Programmer

  • Contract
  • Remote

SimulStat

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Responsibilities:

  • Generate analysis datasets, tables, figures, and listings to support the statistical analysis of clinical trials data in support of regulatory submissions and publications.
  • Generating SDTM domains, ADaM datasets
  • Providing programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells;
  • Writing SAS programs to generate derived analysis datasets, perform analysis, and TFLs, performing ad hoc flexible and rapid programming arising from questions generated from planned analyses and results;
  • Performing programming validation to ensure the quality of analysis datasets and programming outputs; ensuring consistency and adherence to standards within the project;
  • Creating Define Files and converting TFLs to the required format for eSubmission,
  • Providing programming support for the preparation of integrated reports, submissions and post-submission activities;
  • Converting, verifying and integrating multiple sources of incoming data for the creation of analysis datasets; serving as a coordinator when multiple programming resources (e.g. CROs or contractors) are used
  • Contributing to the creation, maintenance, and validation of standards for outputs and macros.

Basic Qualifications:

  • Bachelor’s degree in computer science, statistics, mathematics, life sciences or other relevant degree.
  • 7 years of statistical programming experience in the pharmaceutical/biotechnology industry.
  • Strong understanding of CDISC standards, including SDTM and ADaM models and experienced in implementing these models
  • In-depth knowledge of FDA/ICH guidelines and industry/technology standard practices.
  • Demonstrated proficiency in using SAS to produce derived analysis datasets and produce tables, figures, listings, (TFLs) and graphs (required for adhoc analysis).
  • Working knowledge of Pinnacle 21
  • Experience working with raw data (Rave) and overall knowledge of Rave database/data structure. 
  • Experience working on PK data/analysis

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