Senior Statistical Programmer

South Plainfield, New Jersey

 Katalyst Healthcares and Life Sciences
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RESPONSIBILITIES:
  • Creation of SAS programs to Develop or Validate SDTM/ADaM/TLFs.
  • Provide oversight for CRO SDTM/ADaM/TLFs deliverables for multiple studies and make sure efficiencies are gained at project level.
  • Generate and/or review of SDTM mapping specifications, annotated CRFs, ADaM specifications, Define.XML documents and reviewer's guides per CDISC and FDA specifications and guidelines using standard tools and templates.
  • Interact with Biostatistics and Regulatory to design and prepare regulatory submission-ready packages and support responses to health authority information requests.
  • Provide technical leadership, problem solving of moderate to high complexity and within project timelines while providing high quality deliverables.
  • Demonstrate expertise in the SAS language, procedures, and options commonly used in clinical trial reporting - including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH.
  • Create all files, documents, and analyses necessary to support electronic submission(s) in an eCTD format, including ISS/Client.
  • ccountable for oversight of Statistical Programming deliverables on project level for inhouse and outsourced projects.
  • Manage all aspects of Statistical Programming deliverables for multiple studies/projects.
  • Support in development and review of global standards, templates, processes, SOPs and Work Instructions.
  • Partner with cross functional groups on timelines, vendor selection and CRO oversight.
  • Expertise in the SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH.
  • Experience in development and validation of CDISC SDTM and ADaM data models by transforming raw data into standard domains and development and validation of Tables/Listings/Figures.
  • Extensive experience of data integration.
REQUIREMENTS:
  • BS or MS in Computer Science or Biostatistics & Life Sciences.
  • Minimum of 6 years of industry experience in Statistical Programming to include oversight of CRO deliverables.
  • Must possess the ability to work in a team environment.
  • Excellent written, verbal, and interpersonal communication skills.
  • Creation of all files, documents, and analyses necessary to support electronic submission(s) in an eCTD format, including ISS/Client.
  • Good knowledge of 21CFR11 and GCP.
Date Posted: 26 May 2025
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