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Sr. Statistical Programmer

Sr. Statistical Programmer

Katalyst Healthcares and Life SciencesMountainside, NJ, United States
9 days ago
Job type
  • Full-time
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 (e.g. Clintrials.gov, 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 studies.
  • Primary interfaces : Provider Functional Manager, Pharmaceutical Point of Contact, Janssen project lead programmer.

Requirements :

  • Programming or biostatistics staff from partner contract research organizations (CRO's) in support of deliverables based outsourced projects.
  • Bachelor's degree with Minimum 4+ years of experience or higher and / or equivalent in computer science, mathematics or other scientific field (or equivalent theoretical / technical depth).
  • Demonstrated written and verbal communication.
  • bility to work remotely.
  • High level experience in the implementation of SAS (Base and Macro) in the analysis of clinical trial data.
  • Working knowledge of clinical trial data (Study population, safety, efficacy, PK / PD) in the therapeutic are being serviced.
  • Demonstrated understanding of current industry standards for submission of clinical trial data.
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    Sr Statistical Programmer • Mountainside, NJ, United States

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