

Title:    Scientific
Director of Statistical Modeling and Simulation

Requisition #:        4146130318  

URL:           http://bit.ly/14valrL


Scientific Director of Statistical Modeling and Simulation

Janssen Research & Development, LLC, a Johnson and Johnson Company is hiring a Scientific Director of Statistical Modeling and Simulation to be located at our Spring House, PA or Raritan, NJ facility.
 
Janssen Research and Development, LLC develops treatments that improve the health and lifestyle of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders and reproductive medicine.
 
The Scientific Director of Statistical Modeling and Simulation will be responsible for identifying opportunities to utilize innovative designs and statistical analysis methods in drug development.  She/He will be proposing/developing innovative designs and analysis methods and evaluating them via simulation studies and other appropriate instruments.  This person will be interacting with clinical teams to ensure the proper implementation of innovative approaches in clinical trials and development programs.  They will be participating in strategic planning and supporting the broad implementation of innovative approaches across clinical development.  She/He will be providing/arranging internal training on innovative designs and methods to ensure adequate knowledge and awareness of these approaches in the company.  This person will be serving in internal Independent Data Monitoring Committees for trials involving innovative approaches requiring unblinded interim analyses; and maintaining external collaborations and interactions (via professional associations, participation in conferences, publications, etc) to influence the external pharmaceutical industry and regulatory environment.

Qualifications:

A Doctorate (Ph.D.) in statistics or related field with of 10 years experience in drug development and/or applied quantitative methods for decision making, significant knowledge of scientific programming OR a Masters (MS) in statistics or related field with of 20 years experience in drug development and/or applied quantitative methods for decision making, significant knowledge of scientific programming is required

A familiarity with industry principles of drug development, modeling and simulation, clinical pharmacology, clinical trial design and regulatory guidelines is required

Working knowledge of statistical software, such as SAS, R, and S-PLUS is required

Sound knowledge of biostatistics applied to clinical trials and model-based drug development are required

Experience with trial simulations to design and document adaptive trials and have working knowledge of Bayesian methods is preferred by staying current with the latest statistical methodologies with focus on trial optimization, simulation and adaptive designs

Experience and knowledge of Good Clinical Practices and regulatory requirements for clinical drug development, including the conduct of clinical trials is preferred

Excellent verbal and written communication skills, including formal presentation skills; Experience presenting to technical and lay groups at public meetings; Written skills as evidenced by publication and journal articles also 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 are required

 		 	   		  
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