Janssen Research & Development, LLC, a Johnson and Johnson Company is hiring a Senior Biostatistician to be located in Raritan, 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 visit http://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 Senior Biostatistician will support the oncology area with a focus on: hematologic malignancies, prostate cancer and lung cancer; cancer interception with the goal of developing products that interrupt the carcinogenic process; biomarkers that may help guide targeted, individualized use of our therapies; as well as safe and effective identification and treatment of early changes in the tumor microenvironment.
- Provide statistical input into the clinical development of drugs for treatment of cancer.
- Work with the clinical team in designing clinical studies, leading/authoring the statistical analysis plan, conducting the statistical analysis, and providing statistical input to the clinical study report.
- Provide input in the preparation of scientific presentations and manuscripts.
- Participate in process improvement, training, standards development and enhancing statistical technical expertise.
- Liaise with other statisticians within the organization, building working relationships with therapeutic area leaders, internal SAS programmers, clinical trial managers, and personnel from regulatory affairs, medical writing, and other disciplines as needed.
- 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 Master’s degree in Statistics or related field with at least 4 years of clinical data analysis experience is required OR a PhD in Statistics or related field is preferred.
- Working knowledge of statistical software such as SAS, R, or SPlus is required.
- Experience and knowledge of Good Clinical Practices and regulatory requirements for clinical drug development, including the conduct of clinical trials is preferred.
- Excellent verbal and written communication skills, including formal presentation skills are required.
- Excellent analytical skills are required.
- Experience presenting to technical and lay groups at public meetings is preferred.
- Advanced knowledge of statistical methodology including experience with modeling and simulations is preferred.
Up to 10% travel is required.
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United States-New Jersey-RaritanOrganization
Janssen Research & Development, LLC. (6084)Job Function