Senior Biostatistician
Theravance, Inc. - San Francisco, CA

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Summary and Scope of Position
The biostatistician is responsible for providing statistical support for the design, conduct, analysis, and reporting of Phase 1-3 clinical trials. This individual will work interactively with statistical programming, data management, clinical, and regulatory personnel. He/she may coordinate the work of junior or contract biostatisticians.

Primary Responsibilities
  • Evaluation of study design; sample size calculation; protocol statistical methods
  • Evaluation of case report forms; specification of high-level data edit checks
  • Development of statistical analysis plans; interim and final analyses; report writing and review
  • Ensuring cross-study consistency in design and analysis
  • Support of publications and presentations
  • Statistical input into clinical development strategy
  • Interaction with regulatory agencies
  • Preparation and defense of regulatory submissions
  • Supervision of work by contract research organizations
Job Requirements: Skills and Requirements

A PhD in statistics or biostatistics

5 years of experience in designing and analyzing clinical trials

Programming proficiency with statistical software such as SAS or R

Solid understanding of clinical trial principles, and an understanding of regulatory requirements

Effective verbal and written communication and interpersonal skills

Demonstrated ability to work in a team environment

Must be flexible and work well within a dynamic, interdisciplinary, small company environment requiring multi-tasking and changing priorities

Strong interpersonal, written/oral communication and organizational skills

Theravance, Inc. - 20 months ago - save job - block
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