Janssen Pharmaceuticals Companies of Johnson & Johnson is recruiting for a Director of Quantitative Decision Strategies that can be located in Titusville, NJ or Raritan, NJ.
Janssen Pharmaceuticals Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including in oncology, immunology, neuroscience, infectious disease, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency.
The Director of Quantitative Decision Strategies 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 The successful candidate must have a Doctorate (Ph.D.) in statistics or related field. A minimum of 10 years experience in drug development and/or applied quantitative methods for decision making is required. He/She must have working knowledge of scientific programming. A familiarity with industry principles of drug development, modeling and simulation, clinical pharmacology, clinical trial design and regulatory guidelines is required. Sound knowledge of biostatistics applied to clinical trials and model-based drug development is required. This candidate must have working knowledge of statistical software, such as SAS, R, and S-PLUS. Excellent verbal and written communication skills, including formal presentation skills is required. Experience presenting to technical and lay groups at public meetings is desirable. Written skills as evidenced by publication and journal articles is highly preferred. Ability to successfully multi-task and work independently, under minimal supervision is required. This person must have excellent teamwork skills and the ability to influence, negotiate and communicate with both internal and external customers. This position may be based in Titusville, NJ or Raritan, NJ.
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