Johnson & Johnson Titusville , NJ 08560
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Associate Director, located in Titusville, NJ.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & 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 visithttp://www.janssenrnd.com/ for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The primary responsibilities of the Associate Director will be to identify research study needs, draft proposals and protocols, review study protocols and statistical analysis plans, and provide suggestions to improve them, and contribute to epidemiology strategy and study conduct across multiple therapeutic areas, however, the principal focus of this role is neuroscience.
Other responsibilities include providing technical support for data analysis within the Epidemiology department, scientific support for conducting observational research, and identification and evaluation of data resources to meet study needs. The Associate Director will work closely with colleagues in the Epidemiology group when defining research questions, developing epidemiological protocols, and implementing solutions.
Additional responsibilities may include but are not limited to the following:
Participate in various teams in addressing issues raised by product teams/regulatory agencies
Provide epidemiological and/or statistical/programming support, and disseminate technical information through technical reports, presentations, and publications in peer-reviewed literature as agreed by the teams
Keep up to date with the FDA and other Regulatory Agencies regarding regulatory requirements for Post Approval Authorization Studies and Risk Evaluation and Mitigation Strategy plans
PhD in epidemiology OR an MD with training and degree in Epidemiology is required
At least 3 years of Epidemiology research experience is required
At least 1 years of experience in statistical programming (e.g. R), or database programming (e.g. SQL) is required
Understanding and the ability to interpret quantitative methods is required
Experience with writing protocols in general and particularly the statistical methods sections of study proposals for observational studies and/or proposal requests is required
Experience working with large administrative or medical records databases is required
This position will require someone who can work on multiple projects and with multiple people/teams concurrently
Pharmaceutical or Medical Device and Diagnostics industry experience is preferred
Background / experience in mental health/substance abuse research is preferred
Experience working with health authorities is preferred
Phase III/IV experience is preferred
Knowledge of medical terminologies (e.g. ICD, NDC, SNOMED, MedDRA, LOINC, CPT) is preferred
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-New Jersey-Titusville
Janssen Research & Development, LLC. (6084)