Experience and Requirements
- Doctoral degree in biostatistics/statistics; 10+ years biotech/pharmaceutical experience, including supervisory experience
- BLA/NDA experience including regulatory interactions and advisory committee hearings
- Drug development experience in oncology
- Contribution to peer-reviewed scientific publications from pharmaceutical, biotechnology or public health industry, or academia
- Skilled in programming and working with SAS and R; experience in trial modelling and simulation
- Experience working with quality of life and patient reported outcome data and/or observational research is an advantage
Skills
- Comprehensive knowledge of statistical methodology with demonstrated ability
of applying advanced methods in clinical trials, and RWE study design analysis. - Working knowledge of major statistical software packages
- Ability to interact effectively with management, scientific leadership, consultants and vendors to carry out company decisions
- Excellent verbal and written communication skills in English.
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