Manager Clinical Biostatistics/Statistical Programming

Manager Clinical Biostatistics/Statistical Programming

Immatics

Tuebingen, Germany

Your mission

Your main responsibility will include but are not limited to the following tasks:

• Planning, set-up, execution and quality control of statistical outputs (tables, figures, listings) based on clinical trial data, generating respective texts and discussing results in a cross-functional team to support the development of our drug candidates:
  • Report safety data;
  • Contribute to writing of clinical and regulatory study documents;
  • Answer translational/exploratory questions;
  • Contribute to publication of clinical trial data.
• Provide support across all statistical tasks during the lifecycle of our programs, including clinical study protocol design, statistical analysis plan (SAP) development and the preparation of interim data readouts and finally the clinical study report;
• Support the accurate and complete data collection in the clinical EDC systems in close collaboration with the data management team;
• Oversee accurate completion of biostatistical outputs (SDTM, ADaM, TFLs) generated by external vendors, ensuring that the expected standards are met and that the outputs are in line with the analyses described in the protocol and SAP;
• Contribute to improving data analysis workflows, as well as implementing and executing quality measures to ensure data integrity, in close collaboration with other clinical teams.

Your profile

• You hold a master's degree or PhD in statistics, data science, life science or in a related field, ideally with a focus on clinical biostatistics and statistical programming;
• Industry experience in analysis and reporting of clinical trial data is a plus;
• You exhibit a great attention to detail with strong affinity to answer scientific questions;
• Hands-on experience in programming in SAS, R, SQL and good programming practice are an advantage;
• Ideally, you gained knowledge of applicable clinical research regulatory requirements (i.e. GCP, ICH guidelines);
• We expect a high degree of independent working, analytical reasoning, and good communication skills in English;
• Basic knowledge in immunology, oncology and/or cell and gene therapy is a plus.

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