EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
PhD in statistics or biostatistics with a minimum of 10 years of relevant experience or MS in statistics or biostatistics with a minimum of 12 years of relevant experience. For statisticians with exceptional talent who have demonstrated core capabilities of a Scientific Fellow, 8 years of pharmaceutical experiences with a PhD may be considered.
- Expert knowledge of statistical design/analysis methodology including latest developments and reporting proceduresExtensive statistical and operational knowledge in at least one therapeutic area
- Demonstrated successful track record in working with various development teams
- Active in statistical/pharmaceutical professional organizations at regional or national level.
- Advanced knowledge of the pharmaceutical industry including understanding of clinical drug development process and documents.
- Advanced knowledge of FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials.
- Experience consulting and/or independently representing Statistics function in interactions with regulatory agencies
- Excellent oral and written communications skills.
Expertise in statistical programming, modeling and simulations
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