Principal Statistician

Company: The Steely Group
Location: Cambridge
Posted on: March 16, 2023

Job Description:

Job Description
Location: Hybrid / Remote
Our client is looking for self-motivated, creative problem solvers who are excited by the idea of working in a fast-paced start-up environment and contributing to their growth. They are looking to add a Principal Statistician to their team who will provide statistical expertise in support of clinical development. The person in this role will proactively collaborate with key stakeholders and strategically contribute to project decisions with a focus on study design, analysis, reporting, and proper interpretation and presentation of results.

Responsibilities:

• Key contributor to study design and analysis of clinical data related to company's development programs.
• Efficiently and effectively coordinate statistical activities for multiple studies, including development of protocols and statistical analysis plans and presentation of results in clinical study reports and other relevant documents.
• Support planning and execution of integrated analyses for regulatory submissions.
• Oversee the work of CROs that are performing statistical activities.
• Program in SAS to summarize results as needed.
  Qualifications:
  
  • MS or Ph.D. in Statistics, Biostatistics or equivalent required.
  • Minimum 5 years of Biostatistics experience in drug-development and clinical research.
  • Experience partnering with CROs to manage timelines and deliverables.
  • Must be able to explain statistical techniques and considerations to non-statisticians.
  • Strong communication skills and the ability to work collaboratively with the clinical project team.
  • High attention to detail including ability to manage competing priorities.
  • Ability to program using SAS.
  • Prior experience with IND/BLA/NDA/MAA submissions.
  • Working knowledge of relevant FDA, EMA and ICH guidelines and regulations.
  • Must be flexible and work well within a dynamic, interdisciplinary, small company environment requiring multi-tasking and changing priorities.
  • Ability to travel to various meetings including overnight trips. International travel may be required.
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Keywords: The Steely Group, Cambridge , Principal Statistician, Other , Cambridge, Massachusetts