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Starting as a small Contract Research Organization (CRO) specialized in conducting early phase safety and efficacy trials, bioskin has grown into a full-service CRO offering global dermatologic consulting and regulatory services and all services for management of Phase I-IV drug trials and claim support/safety studies.
We are looking for an
Statistician (f/m/d) in Hamburg, Germany
in clinical trials to join our team.
Your main responsibilities:
- Planning, coordination, development and quality control of statistical analyses
- Development of statistical sections of trial protocols
- Conduct of sample size determinations/power analyses
- Generation trial randomizations
- Development of statistical analysis plans (SAP)
- Programming of statistical analyses (tables, listings, figures) according to SAP
- Programming of analysis data sets according to the CDISC ADaM standard
- Validation of SAS programs
- Develop and assist in maintenance of department tools, templates, guidelines, SOPs, and systems
Profile:
- University degree in statistics/mathematics or other comparable degree
- At least 2 years of experience as statistician and/or statistical programmer within the pharmaceutical industry/CRO
- Working knowledge of ICH GCP guidelines
- Experience in development of data structures according to CDISC standards (STDM, ADaM)
- Dependable, well-structured and organized, target-oriented personality, team player
- Well versed in English (written and spoken)
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