• Database Setup (IDB): Planning, execution, and quality control of statistical and programming activities for the integration of clinical databases.
• Statistical Analyses: Design, execution, and oversight of statistical analyses for individual clinical studies and integrated datasets.
• Study Planning: Providing statistical input for clinical development programs, study protocols, and regulatory documents (e.g., CTDs).
• Meta-Analyses: Conducting meta-analyses for effectiveness comparisons with competitor products.
• Cross-Functional Collaboration: Advising internal R&D teams on statistical topics and interpretation of results.
• Publications: Contributing to and reviewing scientific publications and presenting statistical results.
• Regulatory Interactions: Coordinating and discussing statistical aspects with regulatory authorities.
• Process Optimization: Continuously improving biostatistics processes to meet evolving regulatory and organizational requirements.

• Graduate studies in Statistics, Mathematics, Epidemiology, Computer or Data Sciences
• At least 3 years experience in Biostatistics
• Experience with SAS, CDISC, ICH, GCP, FDA guidelines
• Experience with intergrated databases and EDC systems
• Fluent English skills, German is a plus

• Experience in exciting and international projects
• Continuous salary development
• Da Vinci Corporate Benefits
• On-the-job training and language courses
• Appreciation, motivation and commitment

Nothing provides more motivation than success. Da Vinci Engineering is highly committed to ensuring the own employees' success. Become a part of us!