Requirements:
1. Responsible for statistical integrity, adequacy and accuracy of the clinical projects.
2. Responsible for planning, coordinating, and providing statistical analyse, summaries and reports of studies in support of product development and BLAs.
3. Writing the statistical sections of clinical protocols, participating in clinical team meetings to provide guidance on statistical issues, reviewing data management plans, creating randomization tables, and facilitating electronic data transfers as needed.

Qualifications:
1. Requires an MS in biostatistics, Ph.D. preferred with 6-8 years experience working in an environment that required the ability to set priorities and meet deadlines.
2. Experience with management and statistical analysis of data obtained from phase I-III clinical trials or studies in support of BLAs/NDAs.
3. Requires strong biostatistics skills, experience with major statistical software packages such as SAS and S-plus, excellent organizational, interpersonal and communication skills, and proficiency in various software applications such as MS Word, Excel etc.

For more information, please visit the following

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