YOUR PROFILE

• University degree in data science, statistics, computer science, or comparable studies
• At least two years of professional experience as a data manager with responsibility for clinical studies
• Ability to understand and follow SOPs, working instructions and relevant guidelines
• Knowledge of CDISC standards (CDASH, SDTM, define.xml, cSDRG)
• Knowledge of relevant terminology in clinical and non-clinical research
• Knowledge of relevant guidelines GCP, ICH
• Quick comprehension and analytical thinking
• Team player with high degree of initiative
• Good English skills, German is an advantage

ABOUT US

Staburo GmbH is a data science company, specialized in statistical consulting, programming and bioinformatics for healthcare projects. Our core competencies include Clinical Statistics, Translational Medicine & Biomarkers, Phase I & Pharmacokinetics/-Dynamics, Data Transparency & Disclosure Services, Health Technology Assessment and Bioinformatics. Our customers are international pharmaceutical companies, CROs, biotech companies and medical device manufacturers. Our steadily growing team supports our clients efficiently from study design to data analysis and finally the disclosing and posting of trial results

• CRF design
• Database design and set-up
• Creation of Data Management Plan and Data Validation Plan
• User acceptance testing (including creating testing scenarios)
• eCRF completion guideline
• Data cleaning, SAE reconciliation, query management
• Medical coding (e.g., MedDRA, WHO-DD)
• Programming of plausibility checks
• User Access Management
• Creation of SDTMs, define.xml and cSDRG is an advantage