Tasks

- Review of trial documentation and provision of inputs on study set-up from a statistician’s perspective
- Define trial analysis data sets and metadata
- Act in close cooperation with the lead statistical programmer for the design and implementation of trial analysis data sets and metadata
- Develop programs, tables, listings figures and statistical analyses for reports and trial documentation
- Follow company-specific guidelines and standard operation procedures

Qualifications

- University degree in mathematics, informatics or similar alignment
- At least 5 years of experience in statistical programming within the pharmaceutical industry
- Experience in SAS programming and with statistical analysis in clinical trials
- Good knowledge of CDISC, SDTM and ADAM and basic knowledge of R
- Experience in the review of trial documentation from a statistical programming perspective
- Good understanding of clinical trials from initiation till study completion
- Profound knowledge of ICH-GCP guidelines
- Fully business fluent in English
- Independent, structured and solution-oriented