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Manager of Clinical Biostatistics, Diabetes-7504131219
Description
Janssen Research & Development, LLC, a Johnson and Johnson Company is hiring a Manager Clinical Biostatistics to be located in Raritan, NJ.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer’s disease, epilepsy, migraine prevention and treatment), pain management, and women’s health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market – from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenpharmaceuticalsinc.com
Supporting Diabetes studies, the Manager of Clinical Biostatistics will provide statistical input to clinical development of drugs for diabetes. They will 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. They will serve as the primary contact to outside investigators in the preparation of scientific presentation and manuscripts. They will take a leadership role in process improvement, training, standards development or enhancing statistical technical expertise. The Manager of Clinical Biostatistics will 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 discipline as needed. Will additionally work with external partners including key opinion leaders, may work with external regulatory agencies and advisory committees, and contract research organizations.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Qualifications
A Master’s in Statistics or related field with at least 8 years of clinical experience is required OR a PhD in Statistics or related field with at least 6 years of experience is preferred.
Experience working in a Diabetes clinical environment is preferred.
Working knowledge of statistical software such as SAS, R, or SPlus is required.
Demonstrated experience managing workflow in a cross functional matrix organization is required.
Experience and knowledge of Good Clinical Practices and regulatory requirements for clinical drug development, including the conduct of clinical trials is required.
Excellent verbal and written communication skills, including formal presentation skills is required.
Experience presenting to technical and lay groups at public meetings is required.
Written skills as evidenced by publication and journal articles is preferred.
Ability to successfully multi-task and work independently, under minimal supervision; excellent teamwork skills are required.
Ability to influence, negotiate and communicate with both internal and external customers is required.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:North America-United States-New Jersey-Raritan
Organization: Janssen Research & Development, LLC. (6084)
Job Function: Biostatistics
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Manager of Clinical Biostatistics, Diabetes-7504131219
Description
Janssen Research & Development, LLC, a Johnson and Johnson Company is hiring a Manager Clinical Biostatistics to be located in Raritan, NJ.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer’s disease, epilepsy, migraine prevention and treatment), pain management, and women’s health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market – from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenpharmaceuticalsinc.com
Supporting Diabetes studies, the Manager of Clinical Biostatistics will provide statistical input to clinical development of drugs for diabetes. They will 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. They will serve as the primary contact to outside investigators in the preparation of scientific presentation and manuscripts. They will take a leadership role in process improvement, training, standards development or enhancing statistical technical expertise. The Manager of Clinical Biostatistics will 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 discipline as needed. Will additionally work with external partners including key opinion leaders, may work with external regulatory agencies and advisory committees, and contract research organizations.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Qualifications
A Master’s in Statistics or related field with at least 8 years of clinical experience is required OR a PhD in Statistics or related field with at least 6 years of experience is preferred.
Experience working in a Diabetes clinical environment is preferred.
Working knowledge of statistical software such as SAS, R, or SPlus is required.
Demonstrated experience managing workflow in a cross functional matrix organization is required.
Experience and knowledge of Good Clinical Practices and regulatory requirements for clinical drug development, including the conduct of clinical trials is required.
Excellent verbal and written communication skills, including formal presentation skills is required.
Experience presenting to technical and lay groups at public meetings is required.
Written skills as evidenced by publication and journal articles is preferred.
Ability to successfully multi-task and work independently, under minimal supervision; excellent teamwork skills are required.
Ability to influence, negotiate and communicate with both internal and external customers is required.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:North America-United States-New Jersey-Raritan
Organization: Janssen Research & Development, LLC. (6084)
Job Function: Biostatistics
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.