TERMS

REQUIREMENTS

• PhD biostatistics or related discipline
• Clinical science background
• Statistical leader
• Strong consulting skills
• 5+ years clinical trials experience in industry or academic setting
• Observational data analysis
• Has published in a journal on clinical outcomes

TERMS

DESCRIPTION

• For assigned clinical development project(s), provides statistically sound experimental design and data analysis input to meet project objectives and FDA statistical requirements.
• Develops study analysis plans as a team member under the direction of permanent staff.
• Reviews case report forms to ensure that protocol objectives are met and project standards are maintained.
• Develops statistical programs as necessary to perform analyses, prepare data displays, and verify data accuracy and validity.
• Produce statistical analysis results in the clinical study report. Perform quality control of documents. Write statistical sections of documents.
• Prepare graphics for publications and presentations.
• Provides support for investigator publications.
• Perform computer simulations to determine operating characteristics of tests. Perform sensitivity analyses.

• Experience with statistical software packages such as SAS and S-Plus.
• Sound knowledge of applied statistics.
• Effective communication skills.
• Effective team contributor.

HOW TO APPLY