Associate Director, Biostatistics – Early Phase

Required Skills, Experience and Education

• Ph.D. or M.S. in Statistics/Biostatistics, a minimum of 5 years (for Ph.D.) and 8 years (for M.S.) of experience in biotech/pharma industry as a statistician for clinical trials.
• Hands-on experience in design and analysis of oncology trials is a must.
• Ability to work independently and within a team.
• Ability to apply statistical knowledge to solve real-world problems and acquire new knowledge in advanced statistical methods (e.g., Bayesian methods, predictive modeling etc.).
• Excellent verbal and written communication skills are required.
• Good interpersonal and project management skills are essential.
• Proficiency in SAS and/or R.

The Opportunity

This position is to serve as a study level statistician for oncology studies, and to coordinate activities with other functional groups to ensure timely deliverables. Represent biostatistics on study/project teams. Provide statistical expertise for design, analysis and reporting of clinical studies. Collaborate with various functions on study design and planning, protocol development, statistical methodology and analysis. Develop statistical analysis plans and analysis specifications. Collaborate with statistical programming to ensure that analysis is conducted per statistical plan and specifications. Collaborate with data management and clinical operations to ensure robust CRF and database development and quality data collection. Provide statistical input to regulatory interaction and response to health authority submissions. Collaborate in publications, assist in data interpretation, and ensure consistency and accuracy in data presentation. Contribute to the development of functional-level standards, SOPs, and templates. Keep abreast in new developments in statistics, drug development, and regulatory guidance and share knowledge with functional and cross-functional team members.