Biostatistics - Assistant/Associate Director

Responsibilities include, but are not limited to, serving as the manager of an assigned group of statisticians and or statistical programmers, providing statistical direction and technical oversight, reviewing protocols and case report forms for soundness of the clinical trial design, writing statistical methodology section of the protocol, and preparing statistical analysis plan and computer programs, collaborating with clinical research scientist, clinical research associate, clinical data manager, and medical writer to provide statistical support for regulatory submission to government agencies, cleaning database, analyzing data, writing/reviewing the statistical section of clinical trial reports and participating in various statistical activities, assisting in presenting and defending statistical results to government agencies, and assisting in other tasks as needed.
REQUIREMENTS
Successful candidate will have a Ph.D. in Statistics or Biostatistics with at least 8 years of industrial clinical trial experience (including 1 – 3 years of line management experience). Leadership and team skills, excellent verbal and written communication skills, excellent interpersonal skills, and proficiency with statistical software, particularly SAS, are essential. Knowledge of current U.S. and international regulatory requirements that relate to statistical considerations for IND/NDA (BLA) is preferred. The incumbent must be computer literate in MS Windows-based applications, possess excellent communication skills, including the ability to speak, write and understand English to comply with written procedures, instructions, SOPs and other documents. Resume must include salary requirements for consideration