Manager Clinical Biostatistics/ Statistical Programming*
- Planning, set-up, execution and quality control of statistical outputs (tables, figures, listings) based on clinical trial data, generating respective text passages and discussing results in a cross-functional team to support the development of our drug candidates:
- Reporting of 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 the clinical teams.
- 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.
- Minimum of 3+ years industry experience in analysis and reporting of clinical trial data (mandatory).
- 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 worked already with eCRFs and JReview and 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 required.
This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer.