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Title:Sr Principal Biostatistician
Salary:Open
Experience:2+
Location:NJ - East Hanover

Description:
The Senior Principal Biostatistician can assume the role of an independent Program Statistician for a large and complex clinical development program and/or takes a significant technical leadership role within a TA, globally.

Responsibilities:
  • Be the independent statistical leader and project manager for all CIS deliverables globally for a large and technically complex clinical development program, including supervisory functions like appraisals of full-team members.
  • Ensure that clinical development program meets scientific, regulatory, quality and commercialization requirements, through interaction with the IPT (GPT) and ICT (GCT) (e.g., drive CDP and TPP development from a statistical perspective).
  • Be a scientific leader/expert within a TA, showing leadership/be the point of reference in statistical methods, regulatory guidelines, project strategies, clinical development planning and study design in specific indications.
  • Perform matrix management of CIS project team, and mentor staff as required.
  • Ensure quality of scientific contributions, integrating input from ECD-Biostatistics, Methodology, Modeling and Simulation and external experts. Initiate and drive innovation by implementing novel methods and innovative designs.
  • Plan and track project level activities for CIS, including value-added tasks, resources and timelines adherence .
  • Establish and maintain project standards (master analysis plan, full development project specifications).
  • Plan and manage submission activities, like SCS, SCE, briefing books.
  • Participate in/lead non-clinical project activities.
  • Interact with Health Authorities and external consultants as appropriate.
  • Support and defend analyses and their interpretation of Health Authority Meetings.
  • Take significant Biostatistics leadership role at FDA Advisory Committee meetings.
  • Evaluate in licensing opportunities.

Requirements:
  • Typically requires a Masters Degree in Statistics with at least 6 years of related experience or Ph.D. in Statistics with at least 2 years of experience.
  • With minimal supervision, apply state of the art statistical/programming and/or PK/PD modeling in the preparation of CSRs, manuscripts, ISSs and ISEs that meet world-wide health authority and medical community standards.
  • Participate in preparation of protocols and CDPs.

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