Principal Biostatistician Job at Advanced Clinical, Deerfield, IL

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  • Advanced Clinical
  • Deerfield, IL

Job Description

The Principal Biostatistician will have experience in all required areas as a Senior Biostatistician. The Principal Biostatistician is a subject matter expert in Biostatistics. They will apply a high degree of statistical expertise to advance and influence clinical programs from a statistical perspective. The Principal Biostatistician will mentor and develop members of the Biostatistics team.

Responsibilities:
  • Exceed expectations and responsibilities of a Senior Biostatistician
  • Serve as statistical lead on complex clinical trials; or serve as portfolio lead across a large suite of studies for a sponsor
  • Serve as statistical lead for Integrated Summaries of Safety and Integrated Summaries of Efficacy
  • Provide statistically sound input on clinical trials; demonstrating solid understanding of all key design components (defining study objectives, study design and plan, study populations, treatment regimens as well as determining sample size requirements)
  • Utilize statistical software to implement advanced statistical methodologies
  • Train and mentor others in task execution
  • Represent sponsor at FDA meetings; respond to requests from regulatory agencies
  • Advise and consult with sponsors regarding regulatory filing requirements
  • Develop department training materials and deliver trainings to the team
  • Drive/facilitate/actively engage in department initiatives
  • Standard Operating Procedures (SOPs)
    • Strong understanding of departmental and company procedures; ability to guide others on procedures
    • Participate in the development and revision of department SOPs
  • Business Development
    • Support the business development process; RFI completion, proposal development, bid defense participation, attendance at industry/scientific meetings, etc.
  • Additional Responsibilities
  • Assist in the preparation and review of monthly financial reporting
  • Promote visibility outside of the functional area and effectively interact cross-functionally and in industry
  • Perform other duties as requested by management


Qualifications:

  • The ideal candidate should have an advanced degree (MS or PhD) in Statistics or a closely related field
  • Minimum of 8 years direct Biostatistics experience in pharmaceutical development or CRO environment
  • Excellent oral and written communication skills, organizational skills, and attention to detail are required

Job Tags

Full time,

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