Biotech/Pharmaceutical

Principal Statistician – Remote

Contract

Penfield Search Partners

Contact: Neisha Camacho/Terra Parsons teamnt@penfieldsearch.com

Job Description: Principal Statistician will provide statistical expertise in support of clinical development. 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.

Accountabilities:

  • Key contributor to study design and analysis of clinical data related to companys 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 multitasking and changing priorities.

Tagged as: Principal Statistician - Remote