Manager, Clinical Biostatistics Job

Company Name:
Janssen Research & Development, LLC. (60
Spring House, PA, US
Johnson & Johnson companies are equal opportunity employers.
Manager, Clinical Biostatistics-9310140710
Janssen Research & Development, L.L.C. is recruiting for a Manager- Clinical Biostatistics located in Spring House, PA with less than 10% travel.
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? disease, epilepsy, migraine prevention and treatment), pain management, and women? 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
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion - Proud to be an equal opportunity employer.
The Manager- Clinical Biostatistics will be working and training on trial design and reporting activities with minimal review. He/she will prepare statistical aspects of development plans for new drug indications with review. He/she will be the statistics representative for cross-functional teams and for review within Biostatistics and Programming, Clinical Development Operations, and Therapeutic Areas.
The Manager- Clinical Biostatistics leads statistical input for at least one disease indication, including review within Biostatistics & Programming, Clinical Development Operations, and Therapeutic Areas. He/she also leads clinical study design, leads analysis planning for clinical studies, leads statistical input to clinical study reports, and provides statistical support to other disciplines associated with clinical statistics. He/she serves as a primary contact with outside investigators in the preparation of scientific presentations and manuscripts. The Manager- Clinical Biostatistics also takes a leadership role in process improvement, training, standards development or an area of technical expertise.
Masters degree in Statistics or related field with 6 years of relevant experience or PhD in Statistics or related field with 4 years of relevant experience is required. Experience with SAS programming and R (statistical software) are required. Basic knowledge of regulatory guidance documents such as ICH guidances is required. Demonstrated written and oral communication skills are required. The ability to work independently is required. Previous experience supporting immunology is a plus. Experience and knowledge in adaptive design is a plus.
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Primary Location:
North America-United States-Pennsylvania-Spring House
Janssen Research & Development, LLC. (6084)
Job Function:
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