Senior/Principal Biostatistician

3 months ago

Philadelphia, United States Penfield Search Partners Full time

Our client is a scientifically-driven leader in the development of Oncology and Immunology therapies whose growing pipeline spans a variety of therapeutic approaches. They are currently seeking project-level Statisticians who, by providing statistical support, will be key contributors to drug development programs across a range of phases. Ideally this role will come in at the Senior or Principal level, but can be flexible based on experience. 

In this role you will:

  • 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.

Qualifications (Minimal acceptable level of education, work experience, and competency)

  • Ph.D. degree in statistics required.
  • 2-5 years of experience in pharmaceutical/biotechnology industries and a broad knowledge of biostatistics.
  • Group Sequential Design experience 
  • Demonstrate ability to work independently in project management and decision making.
  • Able to effectively communicate ideas and to manage programmers in a constructive manner.
  • Ability to use SAS to perform efficacy analyses and validate important 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.

 

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