R help - Apr 2013 - Job Opening, Janssen Research & Development, J&J: Scientific Director of Statistical Modeling and Simulation

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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