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Title:Lead Biostatistician
Salary:Open
Experience:4-6
Location:MA - Cambridge

Description:
Responsible for providing project leadership in Biostatistics for one or more specific company products or a therapeutic area as assigned. You will participate in the development of standards across protocols in protocol development, analysis plans, and file/report specifications.

Responsibilities:
  • Review CRFs and data edits as well as review forms for statistical analyses, interprets statistical results, and prepares clinical study reports including integrated summaries for submissions.
  • Reviews analysis of other study statisticians participating on their project for accuracy, consistency, and quality output.
  • Addresses regulatory issues and/or issues from external development partners.

Requirements:
  • Past interaction with FDA BLA/NDA experience desired but not essential
  • Thorough understanding of statistical principles and clinical trial methodology with the ability to practice and implement them
  • Ability to provide technical solutions to a wide range of difficult problems
  • Solutions are imaginative, thorough and practicable, and consistent with objectives
  • Some knowledge of medical/biological terminology and clinical trial designs in relevant therapeutic areas
  • Able to write and present information effectively.
  • Conversant with SAS programming, and detailed knowledge of SAS procedures and other statistical software
  • Working knowledge of regulatory guidelines relating to statistical analysis, study reports and statistical components of regulatory submissions
  • Effective communicator: able to explain methodology and consequences of decisions in lay terms; able to understand requests for complex analyses, etc.
  • Effective team player; willingness to go the extra distance to get results, meet deadlines, etc.
  • Able to manage many projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change. Must be able to deal with ambiguity
  • MS or PhD in Biostatistics/Statistics and equivalent
  • MS with 6 or PhD with 4 years or more working on clinical trials.

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