Description
We are looking for a
Data Manager (m/f)
Reference: -en
Start: asap
Duration: 6 MM
Place: in Western Switzerland
Branch: Tabakverarbeitung
Your tasks:
- Establish SDTM based standards for the System Toxicology group in collaboration with SDTM standards definition experts
- Prepare SDTM data sets and define .xml files for submission of System Toxicology data to regulatory authorities
- Prepare ISA-Tab data sets
- Perform data QC
- Actively participate in CDISC SEND, Pharmacogenomics/Genetics (PGX) and in-vitro working groups
- Collect, organize and secure historical study data
- Write study Data Management documents/procedures covering specifications for external data transfer, data curation and review tools
- Implement data quality metrics and provide related reports
Your qualifications
- Degree in life sciences, mathematics, statistics, informatics or related disciplines
- Solid experience in data management and usage of SDTM in pharmaceutical or biotech industry
- Hands-on experience of preparing, reviewing and submitting CDISC-compliant datasets to the FDA
- Good knowledge of SDTM v1.5, SEND implementation Guide, SDTMIG-Pharmacogenomics/genetics
- Knowledge of GLP regulations
- Understanding of in-vitro and Omics analyses
- Fluency in written and spoken English
- Agility, team player, project management skills
Skills:
- Biostatistician