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Title:Senior Biostatistician
Salary:Open
Experience:2+
Location:MA - Cambridge

Description:
The Senior Biostatistician/Biostatistician (SB) provides strong statistical support to biostatistics activities pertaining to study projects. The SB has a solid grasp of statistical issues and serves as a statistical expert who provides input to the statistical considerations of clinical development plans and individual study designs. The successful candidate will consistently provide biostatistical guidance to the department towards achieving departmental and corporate visions and goals.

Responsibilities:
  • Writes and leads the implementation of the Statistical Analysis Plan (SAP) and randomization methodology specifications when applicable.
  • Reviews statistical output and provides feedback to the clinical team on the meaningfulness of the results obtained.
  • Writes and reviews the statistical methodology sections(s) of study reports and integrated summary reports.
  • Reviews and comments on regulatory documents such as CSRs, as well as publications and poster presentations of clinical data for professional meetings.

Requirements:
  • PhD/equivalent and 2 years of relevant experience, or MS/equivalent and 4 years of relevant experience
  • Ability to carry out statistical analyses with minimal supervision and provides the proper guidance working with statistical programmers to produce desired statistical output.
  • Ability to read and understand technical documents because of strong statistical background and working knowledge of statistical methods applicable to all phases of clinical trials
  • Ability to provide solutions to statistical issues related to overall clinical development projects, individual studies, biomarker studies and PK/PD data
  • Proficient in the use of statistical techniques that include designs and analysis methods for clinical trial data intended to establish proof of mechanism and proof of concept of new drugs
  • Must have a strong working knowledge of all appropriate relevant regulatory guidances (e.g. ICH, FDA and EMEA)
  • Ability to work independently, take initiative and complete tasks to deadlines with quality
  • Clinical development experience in Oncology is highly desirable
  • Ability to develop and improve internal infrastructure, including development of SOPs

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