Senior Biostatistician @ Danaher
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
Experience Level: Mid-Senior
Work From: Onsite
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