Manager, Safety Signal Detection, Methods and Analysis
Irvine , California
April 02, 2017

Johnson & Johnson MD&D Global Services is hiring for a Manager, Safety Signal Detection, Methods and Analysis. The role can be located in either New Brunswick, NJ, Cincinnati, OH, Irvine, CA, and Raynham, MA.


Caring for the world, one person at a time, has inspired and united the people of Johnson & Johnson for 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. 


With $65 billion in 2011 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. The more than 250 Johnson & Johnson operating companies employ approximately 119,000 people in 60 countries throughout the world


The Medical Device (MD) EPI organization conducts observational research to support product development, licensing and acquisition, product launch, and post-market safety and value assessments of MD products, and fosters methodological excellence across the sector. Housed within the MD EPI organization are the Medical Safety Sciences (MSS) and the Real World Data Analytics & Research (RWDA&R) team.  MSS provides advanced statistical, analytical, and methodological expertise and support to help MD sector advance safety signal detection strategies. The RWDA&R team within MD EPI provides analytical capabilities using large administrative, patient-level databases to answer a variety of questions related to product development, health economics and outcomes research (HEOR), and other clinical or commercial activities.


While MSS activities include the incremental improvement of existing MD operating company signal detection methods, the principal focus will be on evaluation, development, and implementation of novel analytical methods and data sources for safety signal detection and evaluation. These activities would include exploration of various “big data” techniques such as machine learning (supervised and unsupervised), natural language processing, sophisticated visualization, and neural networks for analysis of company safety data along with exploration of other real world data sources (e.g. registries, administrative healthcare claims, electronic health records, and regulatory safety databases, and social media) for signal detection.


The manager will also work closely with the Real World Data Analytics & Research (RWDA&R) group. These may involve statistical analysis / prediction of individual patient outcomes, analysis of disease burden/progression/ co-morbidities, standard of care, cost/reimbursement patterns, market size, site of care, and clinical/health economic outcomes. 

Principal Duties and Responsibilities:
  • This individual will partner closely with colleagues from MD EPI, the larger Epidemiology group, MD Operating Company Post Market Surveillance statisticians, and the Medical Safety organization to identify current challenges in data quality and signal detection and research and develop potential methodological solutions
  • This person will work closely with the MSS Lead to develop strategic initiatives and pilot projects to assess the value of these novel techniques
  • The manager will oversee implementation of pilot projects either by directly implementing and programming novel methods or working in partnership with internal colleagues and/or outside consultants
  • This person will champion transitioning promising pilot methods to implementation and incorporation into standard surveillance across the sector via the Medical Device sector wide operating company complaint database and analytics platforms.
  • Participation in the activities in other MD EPI projects, larger Epidemiology Department and the office of Chief Medical Offer will also be encouraged, along with scientific publication of novel signal detection methods and results. 

  • An advanced degree (PhD preferred) or Master’s Degree in (Bio)Statistics, Computer Science, Applied Mathematics, Data Science, Epidemiology, or related field is required.
  • A minimum of 3 years of relevant experience in related fields is required.
  • Preferably some of which are with medical device or pharmaceutical industry is preferred.  
  • Expert knowledge of standard statistical software (e.g. R OR Python) is required.
  • Additional knowledge of other programming languages (e.g., C, SQL, SAS) is preferred.
  • Experience in the application of neural networks for machine learning as applied to natural language processing, prediction, and classification problems specific to healthcare is required.
  • Experience with machine learning tools and packages such as TensorFlow, Caffe, or Torch is required.
  • A working knowledge of applied epidemiologic, public health or similar principles to aggregate data analysis and trend analysis is preferred.
  • Experience with advanced visualization and network analysis is preferred.
  • Understanding of the strengths and limitations of company and regulatory safety databases is strongly preferred.
  • Additionally, knowledge of and experience with various healthcare databases (e.g., insurance claims data, electronic medical records, and hospital billing data) are preferred.   
  • Excellent oral and written communication skills
  • Including experience presenting to technical and lay groups is desirable.
  • Written skills as evidenced by publication and journal articles is preferred.  

Primary Location
United States-New Jersey-New Brunswick
Other Locations
North America-United States-Massachusetts-Raynham, North America-United States-Ohio-Cincinnati, North America-United States-California-Irvine
MD&D Global Services LLC (6209)
Job Function
Requisition ID

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

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