Associate Director, Biostatistics – Early Phase

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.

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. Level will be determined based on the relevance of experience.

• 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.

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