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Associate Director, Biostatistics

Tarrytown, NY 10591-6707

Posted: 01/10/2023 Employment Type: Direct Hire/Perm Job Category: Data Sciences Job Number: 539803 Is job remote?: No Country: United States

Job Description

As an Associate Director, Biostatistics, a typical day might include:

You will lead efforts of the Biostatistics department with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints and frame statistical approaches to address those questions, design clinical experiments and interventional studies to generate and analyze the resulting data, and work with teams to appropriately interpret the results and make decisions.  The incumbent will represent statistical issues in regulatory agency meetings.  The incumbent will lead the development and delivery of training to non-statistical colleagues, lead the development of new infrastructure and processes, and be active in representing the company in professional associations, conferences, and publications.  As an Associate Director, the incumbent will be responsible for mentoring and overseeing less experienced statisticians, with the potential to manage full-time staff. 

This role might be for you if you can:
  • Represents Biostatistics at Global Clinical Subteams.  
  • Interacts with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statistical Programming, Data Management, Medical Writing, and others to design and analyze clinical trials.
  • Leads contributions to the preparation of material to be used in regulatory interactions, including drafting analysis plan and reviewing TFLs to be used in regulatory meetings, slides for advisory committee meetings, etc.
  • Leads and contributes to process improvement and technical working groups and sets timelines and expectations for the deliverables.  Authors new/revised SOPs and contributes to cross-functional EPIC workstreams.  
  • Evaluates appropriateness of available software for planned analyses and determines needs for use of novel statistical methodology or tools.
  • Prepares presentations and written reports to effectively communicate results to the project team, management, and regulatory agencies.  Co-presents findings to management.  Is involved in research activities for innovative statistical methods and applications in clinical trial development as well as providing training to non-statisticians.  
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