Primary Job Responsibilities:

• Ph.D. in Statistics/Biostatistics with at least 5 years of experience in the pharmaceutical industry, or an M.S. degree with at least 8 years of experience in the pharmaceutical industry
• Experience designing the phase II/III clinical trial protocols, Oncology trial design experience is plus
• Experience designing and implementing several dynamic randomization plans
• Experience with application of a variety of statistical methods and ability to work on complex statistical problems
• Experience forming DSMB, organizing DSMB board meetings, providing data and communicating with DSMB members
• Solid knowledge of SAS and familiarity with other statistical software packages
•  Active participation in randomization development and validation process
• Preparation of statistical analysis plans
• Application of statistical methods and analysis of clinical study data
• Preparation of statistical section of clinical trial reports
• Review of protocols/case report forms/statistical analysis plans/clinical trial reports
• Interact and manage KOLs/CROs and represent the company in external scientific forums including communication with worldwide regulatory agencies
• Have thorough understanding of regulatory guidance and statistical methodology as applied to pharmaceutical development. Have the ability to identify, evaluate and implement as needed innovative statistical methods to provide added value to the company drug development process
• Represent the company in interfaces with regulatory agencies globally