Sr. Statistical Programmer

Katalyst HealthCares & Life Sciences

Full-time Mathematical Science Occupations
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Location
Summit, New Jersey, United States
Posted
June 12, 2026

Job Description


Responsibilities:
  • Services rendered will adhere to applicable Pharmaceutical SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.

  • Creation of ADaM datasets based on current ADaM standards.

  • Creation of Tables, Listings and Figures following Janssen specifications.

  • Creation of Subject Narratives following Janssen templates too support Narrative development.

  • Creation of other ancillary data streams including (but not limited to) clinical registry reporting files ( , EudraCT), Bioresearch monitoring reports (BIMO).

  • QC of all programmed output.

  • Creation and/or maintenance of detailed specification documentation.

  • Development and validation of electronic submission packages that comply with submission requirements from FDA, EMEA and other regulatory agencies as needed.

  • Includes support for standalone studies as well as integration of data across studi...

    • Job Details

    • Job Type
      Full-time
    • Category
      Mathematical Science Occupations
    • Date Posted
      June 12, 2026
    • Application Deadline
      July 22, 2026