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Title:Principal Biostatistician
Salary:Open
Experience:8+
Location:NJ - Branchburg

Description:
This position will be in support multiple non-clinical development activities including but not limited to the development of statistical methods which can be handed of to product development groups including Toxicology, Clinical, and Operations. This may also include the development of master study and analysis plans. The individual will need to develop and maintain good working relationships with multiple functional groups. The individual will need to gain a working understanding of key subject matter dimensions, especially as they relate to the development of acceptance criteria and statistical decision points. The candidate will be someone who thrives in an environment of high expectations, technical excellence, exemplary professional integrity and ethics.

Responsibilities:
  • Develop and validate statistical methods which can be generalized to improve efficiency and rigor across multiple functional groups.
  • Translate statistical methods into efficient modules which can be validated and handed off to subject matter experts.
  • Develop master study and analysis plans.
  • Develop and author new procedures and policies
  • Maintain statistical and scientific competency by staying current with literature and industry trends, especially as they relate to regulatory requirements.
  • Provide training and guidance in the use of appropriate statistical methodology.
  • Assist with the preparation of regulatory documents.
  • Provide supervision as needed to internal or contract personnel.
  • Develop training as appropriate to transfer statistical technology.
  • Provide leadership for championing statistical and scientific excellence in all these actives.

Requirements:
  • MS (8 + years) or PHD (5+ years) in Statistics or Biostatistics
  • In depth knowledge of statistical and modeling software including S-plus, R, NONMEM and SAS.
  • In depth knowledge of modeling related to PK/PD and bioassays.
  • An understanding of molecular and cellular biology, pharmacology, toxicology, physiology and pathophysiology is desirable.
  • Exceptional written and verbal skills.
  • Ability to work collaboratively with multiple disciplines and functions.

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