Principal Biostatistician

2 weeks ago

Wilmington, United States Al Solutions Full time

George Higginson is currently searching for an experienced Principal Biostatistician. He is partnering with a commercial biopharmaceutical company working heavily across the Oncology, Inflammation and Autoimmunity space.

Main Responsibilities:

  • Interact with members of the multidisciplinary project teams to establish project timelines.
  • Provide statistical input to study protocols.
  • Write statistical analysis plans.
  • Monitor internal and CRO project activities including timelines, deliverables and availability of resources.
  • Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming of tables, listings and figures.
  • Interpret study results and provide review of statistical summary reports of study results for accuracy.
  • Assist in writing relevant sections of the clinical study report.
  • Participate and contribute to authoring of Clinical Development Plan.
  • Participate in pre-IND and NDA activities.
  • Participate in the development and enforcement of SOPs and guidelines.
  • Other responsibilities as required.
Requirements:
  • Ph.D. degree in statistics required.
  • 3-5 years of experience in pharmaceutical/biotechnology/CRO industries and a broad knowledge of biostatistics, FDA/EMEA guidelines, and the drug development process.
  • History working independently in project management and decision making.
  • Experienced across Phases I-III.
  • Ability to use SAS to perform efficacy analyses, validating data derivations when necessary.
  • Previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies are highly desirable.
  • Knowledge of multivariate analyses and Biomarker analyses is a plus.

How To Apply:

AL Solutions is a niche Life Science recruitment consultancy. We place professionals across the UK, Europe, the United States and Canada for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations. If you're interested, please apply below. If this position doesn't interest you, please visit our website for a list of more vacancies.

George Higginson

Senior Associate

AL Solutions

george@alsolutions.co.uk

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