Beschreibung
For one of our German Biotech clients we are seeking freelance support as:Senior Biostatistician (M/W/D)
Tasks:
• Generate input to clinical development plans, clinical study reports and regulatory submission materials
• Support and develop the statistical analysis plan for clinical trials
• Establish standards for clinical conduct and data collection, management and/or reporting
• Manage CROs regarding statistical issues and activities to ensure timely delivery of analysis results
• Provide guidelines and standards to CROs
• Represent the Biostatistics department in meetings with cross-functional project teams
Qualification:
• Masters or PhD in the field of Medical Biometry
• Up to 5 years industry experience
. experience in oncology studies (Phase III)
• Profound knowledge of statistical methodology in design and regulatory requirements relating to clinical development
• Experience in submission activities
• Knowledge of statistical methods (Phase I-IV clinical trials)
• Expertise in designing clinical trials
• Knowledge of statistical software “Base SAS”, “SAS Macros”, “Addplan” and “R”
• Extensive knowledge of ICH guidelines, 21 CFR Part 11, and FDA guidelines
• Must Have: Business Fluency in English
• Nice to Have: German
Requirements:
• Start: asap
• Duration: 6 months
• Capacity: 5 days / week preferred, Homeoffice possible