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Title:Senior Biostatistician
Salary:Open
Experience:1-2
Location:CA - South San Francisco

Description:
The Sr. Biostatistician will work with senior biostatistics staff and clinical monitors on clinical development plans, the design and conduct of clinical studies and in the evaluation, interpretation and preparation of study results, and will collaborate in the preparation and review of clinical assessments.

Responsibilities:
  • Provides statistically sound experimental design and data analysis input to meet project objectives and FDA statistical requirements for assigned clinical development project(s).
  • Reviews all project protocols, author protocol statistical analysis sections and generate study randomizations
  • Develops study analysis plans as a team member; lead this effort for selected studies.
  • 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.
  • Authors statistical analysis results in the clinical study report.
  • With help from senior statistical staff, leads team members to author the report.
  • Responsible for seeing the report through the review process.
  • Supplies statistical input for BLA submissions and in response to FDA questions.
  • Provides support for investigator publications.
  • Keeps abreast of new developments in statistics, drug development, and regulatory guidance through literature review, workshop attendance, etc.

Requirements:
  • Ph.D. in statistics/biostatistics with at least 1-2 years of clinical trials experience.
  • 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 communication skills.
  • Effective team contributor.

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