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Title:Sr. Biostatistician
Salary:Open
Experience:4+
Location:CA - South San Francisco

Description:
The 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:
  • Bachelor or Master's degree in Statistics, Computer Science, Mathematics, or a related science discipline.
  • Minimum 4 years experience in SAS Programming for Phase I-IV clinical trials in a pharmaceutical or CRO setting.
  • Required Skills: SAS-Base, MACRO, STAT, GRAPH, CDISC, ACCESS, MS Office products.
  • Proven experience with Unix and Windows operating systems.
  • Understand software development life cycle; understand FDA Guidelines.     
  • MUST have strong SDTM experience.

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