Data Manager (m/f)

REFERENZNUMMER:

323691/11

IHRE AUFGABEN:

-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

IHRE QUALIFIKATIONEN:

-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

WEITERE QUALIFIKATIONEN:

Biostatistician