Remote, 12-month contract, potentially renewable
The Senior Statistical Programmer will work closely with the Director of Statistical Programming and other members of the Biometrics team to provide programming support across specific programs. The ideal candidate will provide hands-on programming and validation support to project teams
- Programming and QC of SDTM and ADaM data sets
- Validating data sets and TFLs produced by vendors
- Running compliance checks on SDTM and ADaM data sets
- Re-running another programmer’s code on a monthly or quarterly basis to support programs
- Writing edit check programs to support Data Management
- Minimum of bachelor’s degree in Statistics, Computer Science, Mathematics, or a related technical discipline.
- Minimum of 4 years of experience in clinical research, SAS programming for phase I-IV clinical trials in a pharmaceutical/CRO environment.
- Technical knowledge and experience with SDTM, ADaM, and Define.XML.
- Clear understanding of the drug development process, submission-related activities and regulatory requirements (eg, CDISC, CDASH, eCTD) and guidelines (eg, ICH, CHMP, FDA, GCP).
- Strong knowledge of SAS functionalities (including ODS, SQL, MACRO, STAT, GRAPH, and ACCESS) and experience with MS Office are required. Familiarity or experience with R Software is a plus.
- Proven experience with UNIX and Windows operating systems.
- Ability to effectively communicate and perform in a high demand and dynamic working environment.
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