Principal Statistical Programmer – Safety Biometrics

By | February 17, 2023

SimulStat

Qualifications:

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.