Senior Biostatistician @ Danaher

Job Information

Job Description:

In this role, you will have the opportunity to:

  • Consult with the project teams and apply statistical expertise to ensure scientific validity and proper design of studies, prepare written summaries for use by regulatory agencies and project teams.
  • Provide statistical support to assist with sample size calculations and development of the statistical analysis plan (SAP) for clinical studies and complete SAP throughout lifecycle of the study.
  • Develop statistical programs to perform analyses and prepare data displays by developing standards to ensure quality in standard work incl. dataset structures, macros, and programs for analyses.
  • Contribute to ad hoc explorative analyses for internal understanding, collaborate to generate health economics evidence and publications.
  • Represent CLEAR in cross-functional study teams and proactive contribute to biostatistical advice in line with guidelines and state-of-the art methodologies.

 

The essential requirements of the job include:

  • Five years’ experience in biostatistics in medical device, pharmaceutical and/or academia
  • Experience with in vitro diagnostic (IVD) and/or medical device (MD) products
  • Deep knowledge about design of clinical trial, statistical methodologies, statistical programming using SAS, and interpretation and presentation of complex statistical results.
  • Experience with proactive planning, analyzing, and reporting of clinical studies for clinical diagnostics and/or medical devices e.g., precision, stability, and clinical sensitivity specificity studies.
  • Able to communicate fluently on a scientific and layman level in English, oral and written

It would be a plus if you also possess previous experience in:

  • R programming.
  • Power BI report development.
  • Experience with Blood Gas, Transcutaneous Monitoring, Immunoassays or Sampler for Blood Gas testing

Benefits:
Experience Level: Mid-Senior
Work From: Onsite

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