- 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
- Deep understanding and experience in working with MedDRA and WHODrug coding dictionaries, as well as custom and 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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