Associate Director, Late Development Clinical Biostatistics

Janssen Research & Development, LLC, a Johnson and Johnson Company is hiring an Associate Director, Clinical Biostatistics to be located in one of the following locations: Titusville, NJ; Raritan, NJ; Spring House, PA; Beerse, Belgium.
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 visit 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 Associate Director of Clinical Biostatistics will be supporting the Infectious Diseases and Vaccines / Global Public Health therapeutic areas and will provide late development statistical leadership for development of new therapies.
Principal Responsibilities:
  • Take the lead in working with the team in designing clinical studies, leading/authoring the statistical analysis, plan and provide statistical input to the clinical study report.
  • Serve as the primary contact to outside investigators in the preparation of scientific presentation and manuscripts.
  • Take a leadership role in process improvement, training, standards development or enhancing statistical technical expertise.
  • Be responsible to liaise with other statisticians within the organization, building working relationships with therapeutic area leaders, internal SAS programmers, clinical trial managers, regulatory affairs, medical writing, and other disciplines as needed.
  • Work with external partners including key opinion leaders, may work with external regulatory agencies and advisory committees, and contract research organizations.

  • A PhD in Statistics or related field with at least 6 years of relevant clinical trials experience, or a Master’s in Statistics or related field with 8 years of relevant clinical trials experience is required.
  • Experience and knowledge of Good Clinical Practices and Health Authority requirements for clinical drug development is required.
  • Experience influencing clinical development programs is preferred.
  • Experience with Adaptive Designs, Modeling, and Simulations is required.
  • Proficiency with statistical software such as SAS and R is required.
  • Demonstrated experience managing workflow in a cross functional matrix organization is required.
  • Excellent verbal and written communication skills, including formal presentation skills, are required.
  • Experience presenting to technical and lay groups at public meetings is required.
  • Written skills as evidenced by publication and journal articles are preferred. 
  • Ability to successfully multi-task and work independently, under minimal supervision, and excellent teamwork skills are required.
  • Ability to influence, negotiate and communicate with both internal and external customers is required.
  • Travel up to 20% both domestic and international will be required.

Primary Location
United States-New Jersey-Titusville
Other Locations
North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Janssen Research & Development, LLC. (6084)
Job Function