Biostatistician (m/f/d)

TASKS

• Planning, execution and documentation of statistical analyses for phase I-II clinical trials
• Input for the study synopsis and study protocol
• Sample size planning and randomization
• Creation and review of statistical analysis plans
• SAS programming and validation of statistical analyses and datasets
• Input for the study report
• Preparation of statistical reports
• Close collaboration with Clinical Data Management, Medical Writing, Project Management and other interdisciplinary departments
• Ensuring compliance with applicable quality, compliance and regulatory requirements.
• Creation of SOPs

QUALIFICATIONS

• Completed studies in biostatistics, statistics, mathematics, bioinformatics, epidemiology or a comparable field
• Professional experience in biostatistics, preferably in the field of clinical trials, in the pharmaceutical industry or at a CRO
• Excellent knowledge of statistical methods, especially in the evaluation of clinical or observational studies.
• Solid programming skills in SAS; knowledge of R is desirable.
• Experience in the creation, testing, and documentation of analysis programs
• Knowledge of regulatory requirements and standards, such as ICH-GCP and CDISC (SDTM/ADaM), is advantageous.
• A meticulous, structured and solution-oriented work style, as well as a strong awareness of quality.
• Excellent German and English skills, both spoken and written.

WE WORK

• Permanent employment contract, 37.5 hours per week, 30 days of annual leave, flexible working hours and flat hierarchies
• Lease-a-bike, company pension scheme, supplementary health insurance and EGYM Wellpass
• Participation in challenging scientific and clinical projects
• A collegial, interdisciplinary working environment
• Comprehensive onboarding and individual training and development opportunities
• Flat hierarchies and a "you-name culture"