Director of Biostatistics

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