Responsibilities will include, but are not limited to, review of clinical trial protocols, case report forms, database specifications, and data management plan for soundness of good clinical practice, design clinical trial for statistical model selection and sample size estimation, write statistical methodology section of protocol, and prepare statistical analysis plan and SAS programs. This professional will collaborate with clinical research scientist, clinical research associate, clinical data manager, clinical database programmer, statistical programmer, and medical writer to provide statistical support for regulatory documentation and/or submission to government agencies. Additional duties include cleaning database, analyzing data, writing/reviewing the statistical section of clinical trial reports, and participating in various statistical activities. This professional may also assist in presenting and defending statistical results to government agencies. Will assist in other tasks as needed.

Successful candidate will have a Ph.D. in statistics or biostatistics with at least 3 years of industrial clinical trial experience. Good verbal and written communication skills, good interpersonal skills, and proficiency with statistical software particularly SAS, are essential. Knowledge of current US and international regulatory requirements that relate to statistical considerations for IND/NDA(BLA) are preferred. Duration of assignment will be for 6 months.

Please forward resume with salary/rate requirements to: Scott --> scott@marshwinds.net