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Title:Principal Biostatistician
Salary:$90-130K
Experience:5+
Location:MA - Lexington/ Marlborough/Norwell

Description:
The Principal Biostatistician will be responsible for providing expert technical guidance to Biostatisticians and other staff on project teams. This individual will oversee the entire design, development and evaluation process for the technical/statistical infrastructure for the conduct and evaluation of all clinical trials, from inception to completion. This individual will be recognized as one of the organization’s elite technical professionals.

Responsibilities:
  • Leads and manages the technical operations of assigned projects and provides technical guidance and mentoring to project team(s).
  • Leads team(s) in the areas of experimental design, protocol development, statistical analysis plans and statistical analysis to meet project objectives, and development statistical section of clinical study reports, INDs, NDAs, and annual reports.
  • Acts as liaison on behalf of department with internal personnel and outside customer representatives at various levels concerning processes or scheduling of specific phases of projects or contracts.
  • Communicates company objectives to the group(s) in a clear and timely manner.
  • May construct estimates of project resource requirements and time lines and routinely provides management with status updates.
  • Keeps abreast of relevant literature and is able to make highly intelligent recommendations regarding new technologies and methodologies to group.
  • Demonstrates innovation and creativity in aligning technology with and driving line of business objectives. Seeks out and plans technical direction for the group(s) and promotes technological innovation.
  • Makes technical presentations, both internally and externally.
    Works independently, applying judgment in determining the best methods and techniques to achieve results requiring evaluation of intangible factors.
  • Ensures compliance with, and participates in development of SOP's and ICH GCP regulations 

Requirements:
  • Ph.D. (or equivalent degree) and minimum of 6 years of relevant experience, or M.S. (or equivalent degree) and minimum of 9 years of relevant experience.
  • Must possess an advanced understanding of modern drug discovery and development processes. 
  • Ideal candidate has demonstrated outstanding diligence and competence in a managerial role, as well as demonstrated advanced and inspiring intellectual and technical leadership.
  • Candidate must also have a proven ability of excellent cross-functional project management skills, including an impressive track record of consistently meeting all project timelines and objectives

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