Scientific Director, Medical Affairs Biostatistics bei Janssen Research & Development, LLC

%3Cfont size=%223%22 face=%22Arial%22%3E%3Cdiv%3EJanssen Research %26amp; Development, LLC., a Johnson and Johnson Company is hiring a Director, Medical Affairs Biostatistics to be located in Titusville, NJ or Raritan, NJ and may require up to 10% travel.%26nbsp;%3Cbr%3EJanssen Research %26amp; Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.%3Cbr%3E%3Cbr%3E%3C/div%3E%3Cdiv%3EIn this position you will supporting Medical Affairs in the Oncology therapeutic area, you will provide critical statistical oversight to Medical Affairs clinical studies and will assume a leadership role in clinical trial and/or patient registries planning (mostly Phase 3b/4 trials or observational studies for post marketing commitments/requirements)%26nbsp; and reporting related activities.%26nbsp; You will also assume the role of a Statistics representative for cross-functional teams and work on several trials (projects) simultaneously.%26nbsp;%3C/div%3E%3Cul%3E%3Cli%3EProvide statistical input for clinical trials, observational studies and other types of clinical research projects including but not limited to post-hoc analyses, investigator initiated studies, publications, and HECOR/Epidemiology/Market Access support.%26nbsp;%26nbsp;%3C/li%3E%3Cli%3E%26nbsp;Contribute/lead clinical study design, analysis planning and for the development of statistical analysis plan (SAP) and data presentation plan (DPS) for MA studies.%26nbsp;%3C/li%3E%3Cli%3E%26nbsp;Provide input to product development and performs statistical functions for submission related activities.%26nbsp; Provide statistical support to other disciplines related to clinical statistics (e.g., HECOR/Epidemiology and publication activities).%26nbsp;%26nbsp;%3C/li%3E%3Cli%3EServe as a primary contact with outside investigators (and vendors) in the preparation of scientic presentations and manuscripts.%26nbsp; %26nbsp;%3C/li%3E%3Cli%3EInteract with external Key Opinion Leaders (KOLs).%26nbsp;%3C/li%3E%3Cli%3E%26nbsp;Pursue rigorous statistical analyses in support of business-critical new research ideas.%26nbsp;%26nbsp;%3C/li%3E%3Cli%3EExplore and implements innovative statistical methods.%26nbsp; %26nbsp;%3C/li%3E%3Cli%3ERepresent department in meetings with regulatory agencies.%3C/li%3E%3C/ul%3E%3C/font%3E

• Ph.D. in Statistics or related field with a minimum of 8 years relevant experience . 
•  Experience working in Medical Affairs Statistics is preferred   
• Experience in the area of Oncology clinical research is required . 
• Experience in other therapeutic areas such as; Infectious Diseases and Vaccines and Immunology is desirable.   
• In-depth working knowledge of statistical software such as SAS, R, is required.  
• Intermediate to advanced proficiency level in applied biostatistical methodology with emphasis on pharmaceuticals is required.  
•  Demonstrated experience as an individual contributor is required while managing workflow in a crossfunctional matrix organization is preferred.  
•  Experience and knowledge of Good Clinical Practices and regulatory requirements for clinical drug development, including the conduct of clinical trials is required.   
• Excellent verbal and written communication skills, including formal presentation skills is required.   
• Experience presenting to technical and lay groups at public meetings is required.  
•  Written skills as evidenced by publication and journal articles is preferred.  
• Ability to successfully multi-task and work independently, under minimal supervision; excellent teamwork skills are required.  
• Ability to influence, negotiate and communicate with both internal and external customers is required

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