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Title:Senior Biostatistician
Salary:Open
Experience:2+
Location:CA - South San Francisco

Description:
The Biostatistician/Senior Biostatistician works with senior biostatistics staff and clinical monitors on clinical development plans; the design and conduct of clinical studies; the evaluation, interpretation, and reporting of study results; and regulatory submissions to the FDA.

Responsibilities:
  • As part of a development assessment team, collaborates in the preparation and review of the clinical development plan.
  • For assigned clinical development projects, provides statistically sound experimental design and data analysis input to meet project objectives and FDA statistical requirements.
  • Reviews all project protocols, author's protocol statistical analysis sections, and generates study randomization.
  • Reviews case report forms to ensure that protocol objectives are met and project standards are maintained.
  • Develops study analysis plans as a team member and leads this effort for selected studies.
  • Develops statistical programs as necessary to perform analyses and prepare data displays.
  • Authors results sections of the clinical study report.
  • Supplies statistical input for BLA submissions and in response to FDA questions.
  • Provides support for publication of clinical trial results.
  • Keeps abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings.

Requirements:
  • Ph.D. in Statistics/Biostatistics with at least 2 years of clinical trials.
  • Experience with statistical software packages such as SAS and S-Plus.
  • Sound knowledge of theoretical and applied statistics.
  • Sound understanding of regulatory guidelines in a pharmaceutical research setting.
  • Effective skills in communication and team collaboration.

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