Principal Statistical Programmer – Safety Biometrics

  • Contract
  • Remote


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  • At least 8 years of hands-on experience in Stat Programming with no employment gaps. 
  • At least 4 years hands-on experience working on SDTM and ADaM data sets
  • Experience in regulatory safety reporting (DSUR/PBRER/PSUR)
  • Experience in performing safety data integration and safety reporting to support signal detection and risk evaluation
  • Experience in working with MedDRA and WHODrug coding dictionaries and customized Standardized MedDRA Queries (SMQs)
  • Experience in macro/utility generation and infrastructure
  • Hands-on experience in oncology and submissions (preparing metadata for a study and/or working on an ISS or ISE)
  • Strong communication skills, both written and verbal
  • Demonstrated attention to detail and focus on quality, supported by examples
  • Demonstrated proactivity, supported by examples
  • Demonstrated analytical skills, for example by creating or providing significant input into specifications as an author or while programming or conducting QC
  • Commitment to work on a US PST schedule (9-5) highly preferred; will consider candidates that can’t commit to the PST schedule on case by case basis.

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