Senior Biostatistician

3 days ago


Wilmington, Delaware, United States Al Solutions Full time
Principal Biostatistician

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

Main Responsibilities:
  • Collaborate with multidisciplinary project teams to establish project timelines and ensure timely completion.
  • Provide statistical input to study protocols and ensure compliance with regulatory requirements.
  • Develop and implement statistical analysis plans to meet project objectives.
  • Monitor internal and CRO project activities, including timelines, deliverables, and resource availability.
  • Guide and supervise programmers in authoring analysis dataset specifications and programming tables, listings, and figures.
  • Interpret study results and review statistical summary reports for accuracy.
  • Assist in writing relevant sections of the clinical study report.
  • Contribute to 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 of working independently in project management and decision-making.
  • Experience across Phases I-III.
  • Ability to use SAS to perform efficacy analyses and validate data derivations when necessary.
  • Previous experience in dealing with Health authorities, such as discussions/negotiations in filing strategies, is 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. If you're interested, please apply below. If this position doesn't interest you, please visit our website for a list of more vacancies.



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