Biostatistician (m/f)

- Responsible for the coordination and supervision of the statistical activities outsourced to external service providers, for the preparation of electronic submissions, and for programming the in-house analysis of the pre-clinical and clinical trials
- Major accountabilities:
- Develop study designs and statistically relevant parts of the study protocols
- Coordinate and supervise service providers on statistical activities for a clinical study
- Develop and review statistical analysis plans (SAPs)
- Program in-house analysis (derived datasets, tables and listings) using SAS for preclinical and clinical trials
- Develop SDTM and ADaM datasets for electronic submissions in cooperation with service providers
- Generate ICH-compliant submission documents and process authorities’ requests
- Provide innovative ideas for designing and analyzing clinical studies and support the set-up of statistically relevant processes and SOPs
- Diploma in Statistics or Mathematics or related field
- Profound experience as a biostatistician for clinical trials in the pharmaceutical industry
- Intermediate to expert experience of SAS programming (including SAS macro language) and experience in using NQuery Advisor for sample size calculations
- Ability to coordinate statistical activities for a clinical study
- Experience in CDISC standards
- Good understanding of global clinical trial practices, procedures and methodologies
- Good team player, good business ethics
- Very good English (oral and written), German an advantage

Weitere Qualifikationen: Biostatistician, Software developer