Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies, is recruiting for a Scientist - Pharmacometrics, located in Raritan, New Jersey.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.

We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal.Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

The position is responsible for the co-development and execution of Pharmacometrics (pharmacokinetic [PK] and pharmacodynamic [PD]) Modeling and Simulation activities related to the research, design, implementation, data analysis, interpretation, reporting, and publication of ClinPharm-sponsored and -supported studies for products in any phase of development. Additional responsibilities include the generation and review of clinical pharmacology documents related to regulatory submissions, preparing responses to Agency questions and preparing for and/or attending meetings with Regulatory Agencies and Advisory Committee Meetings.




Key Responsibilities:

• Participates in review and or development of the Case Report Form, Completion Guidelines, Patient Diary, Laboratory Requisition Form to ensure accuracy of information related to clinical pharmacological sampling (blood, plasma, urine, etc.) during study conduct
• Program and generate population PK / PKPD ready datasets in an SPLUS, R or SAS software environment in close collaboration with the Pharmacometrics Scientist or Pharmacometrics Leader to perform the population-PK / PKPD modelling. This work includes consistency checks to ensure delivery of high-quality ClinPharm data within a specified time frame.
• Coordinate the construction of appropriate database specifications / database structures in order to efficiently outsource the dataset preparation to an external partner if needed.
• Help out Pharmacometrics Scientists and Pharmacometrics Leaders in the generation of tables and graphs for Summary Overviews, Study Summary Results, Clinical Study Reports, internal and external departmental data communications and submission-related documents
• Performs Pharmacometrics QC checks when applicable
• Involved in process development such as PK data flow working groups
• In collaboration with Pharmacometrics Scientist or Pharmacometrics Leaders, apply state-of-the-art tools for PK and PK/PD model building or, when appropriate, contribute to specialized analyses, such as allometric scaling, IVIVC, PB/PK modelling (Senior Associate Pharmacometrics Scientist)

• Ph.D. Degree OR PharmD Degree is required, OR a M.S. Degree with at least 6 years of relevant experience in the areas of clinical pharmacology, modeling/simulation, statistics, engineering OR other related areas.
• Applied working knowledge of non-linear mixed effect modeling is required
• Hands-on knowledge of PK & PD Nonlinear Mixed effect modeling software packages is required
• A fundamental understanding of clinical PK & PK/PD population PK modeling concepts is required
• A fundamental understanding of clinical drug development is preferred
• A fundamental understanding of ICH and other relevant regulatory guidelines and regulations is preferred
• Excellent communication skills are required
• This position is located in Raritan, NJ, and may required up to 10% travel.