- Apply statistical techniques to facilitate better decision-making and improve business operation.
- Regularly interact with management of different levels in strategy meetings. Contribute to strategic planning to ensure statistically optimized non-clinical development plans and assist in the creation of strategic objectives for regulatory filings.
- Participate in the planning/design, conduct, analysis, and interpretation of non-clinical studies and regulatory submissions.
- Collaborate with colleagues from other departments to ensure compliance with regulations and help implement regulatory initiatives such as Quality by Design and process validation
- Participate in establishing departmental and non-clinical SOPs and guidelines.
- Develop statistical tools to streamline process development, QC testing and troubleshooting.
- Prepare statistical courses and provide training to scientists.
- Develop and deliver statistical and scientific publications and present internally and externally.
- Collaborate with other statisticians in improving and sharing statistical approaches.
- MS or PhD in Statistics, Biostatistics, or a highly related field.
- At least 2-4 years (PhD) or 6-8 years (MS) of experience in pharmaceutical development and applied statistics/statistical consulting required
- Must have comprehensive knowledge of applied statistical principles and modeling in drug research and development, and proficiency in statistical software such as SAS and R. Must have excellent interpersonal and effective verbal and written communication skills. Creates a learning environment, opens to suggestions and experimentation for improvement. Embraces the ideas of others, nurtures innovation and manages innovation to reality
- Strong leadership skills and experience in managing a programming group.Experience in working/managing in an international team
- Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance. Raises the bar and is never satisfied with the status quo.
- Competent in experimental design, descriptive and inferential statistics, biometrics/ biopharmaceutical applications and computer programming
- Pharmaceutical or related industry experience with nonclinical, clinical or pharmacology studies, as appropriate, including experience and understanding of drug development in the regulated environment preferred
- Learns fast, grasps the 'essence' and can change the course quickly where indicated .