Janssen Research & Development, LLC, a Johnson & Johnson company, is recruiting for a Senior Biostatistician, Clinical Biostatistics. The preferred location for this position is either Titusville, NJ or Fremont, CA. Consideration may be given to Raritan, NJ or La Jolla, CA.
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 http://www.janssenrnd.com/ for more information.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Supporting the neuroscience area with a focus on Alzheimer’s disease and mood diseases;, the Senior Biostatistician will provide statistical input into the clinical development of drugs for treatment of Alzheimer’s disease and mental health. The Senior Biostatistician will work with the clinical team in designing clinical studies, leading/authoring the statistical analysis plan, ensuring accuracy and facilitates the implementation of statistical analyses, providing statistical input to the clinical study report, performing statistical functions for submission related activities, and providing input in the preparation of scientific presentations and manuscripts. The Senior Biostatistician will participate in process improvement, training, standards development and enhancing statistical technical expertise.
The Senior Biostatistician will interface with Biostatistics staff, clinical teams, and associated working groups. This individual will be involved in communication with clinical therapeutic area members, SAS programming, clinical data management, clinical trials management, regulatory affairs, clinical communications, clinical pharmacology, medical writing, and quality management.
They will additionally work with external partners including key opinion leaders in the oncology area, may work with external regulatory agencies and advisory committees, and contract research organizations.
A minimum of a Master’s Degree in Statistics (or Computer Science or Mathematics with pharmaceutical experience) with 4+ years of experience or a PhD in Statistics or related field with at least 2+ years of experience is required. Knowledge of SAS programming and at least some other significant statistics software (e.g., R, S-Plus, PASS) is required. Experiences with clinical trials and knowledge of regulatory guidance are required. Neuroscience industry experience is preferred but not required. Demonstrated written and oral communication skills and ability to work within a team and work independently are required. Other important requirements include interdependent partnering, building strategic working relationships, mastering complexity, and good decision making capability.
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