Sr. Statistical Programmer

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• 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 to support Narrative development.
• Creation of other ancillary data streams including (but not limited to) clinical registry reporting files (e.g. Clint rials.gov, Eudra
  
  CT), 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.

• 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.
• Ability 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 area being serviced.
• Demonstrated understanding of current industry standards for submission of clinical trial data.

• Seniority level:
  Associate
• Employment type:
  
  Contract
• Job function:
  Information Technology
• Industries:
  Pharmaceutical Manufacturing
• Location:
  
  Summit, NJ

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