Senior Biostatistician

The Senior Research Biostatistician will be responsible for applying innovative statistical methodologies primarily for clinical research primarily and as a support with non clinical research  within the Medical Devices Sector

• Provide state-of-the-art statistical strategies to meet business objectives by offering technical direction and leadership.
• Resolve complex statistical issues from the business units.
  Review protocols for proposed studies and IIS proposals with respect to statistical methodology as needed.
• Provide statistical support during discussions with regulatory agencies.
• Contribute to and co-author peer-reviewed articles independently and/or in coordination with the lead author/physician.

• A minimum of a PhD with 3 year post doc of statistical analysis experience desired 
• A minimum of 5 years in a medically-related position that includes FDA, GCP or relevant area is also required
• Expertise in statistical methodologies in preclinical, clinical, and non-clinical settings is required
• Ability to work independently in addressing research requirements is required
• Ability to make judgments regarding the selection of statistical tests to be performed, and how to present data is also required
• Ability to work effectively within a cross-functional team is required
• Experience working with SAS and R is required
• Experience in designing and analyzing clinical trials, including co‐authoring grant proposals, protocols and peer‐ reviewed publications
• Knowledge of Microsoft packages; PowerPoint, Excel, Word is also required

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