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Requisition ID: 1702603671W
Caring for the world, one person at a time’... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people.
Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
Janssen Research & Development, LLC, a Johnson and Johnson Company, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Statistician.
Janssen Research & Development develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious diseases, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
The Quantitative Sciences organization integrates Clinical and non-Clinical Biostatistics, Clinical Pharmacology, and Model Based Drug Development in a single aligned organization as part of Janssen Research & Development. We work in cross-disciplinary Quantitative Sciences teams and apply quantitative principles across the R&D portfolio to enable optimal decision-making at the earliest time point and in the most efficient manner.
We are specifically looking for a Senior Statistician to work in the Clinical Biostatistics Early Development group. The disease areas that are targeted Infectious disease such as Hepatitis B (HbV) and Respiratory syncytial virus (RSV). The candidate should be able to gain a thorough understanding of the safety, efficacy, the pharmacokinetics and the pharmacodynamics of one or more investigational compounds. He/she will be involved in the design, set-up and analysis of the clinical trials in close collaboration with other clinical team members. The team is looking for a candidate who has the ability to understand and apply innovative designs and analysis methods and supporting their evaluation via analytical studies and other appropriate methods. Knowledge in regulatory submissions is required.
Candidates not meeting one or more of below requirements will still be considered provided unique expertise in one or more relevant areas can be demonstrated.
- Ph.D. in Statistics or related field with about 2 years of relevant experience, or Masters in Statistics or related field with at least 5 years of relevant experience. Experience with neuroscience drug development is a pre
- Proficient in SAS or R programming
- Basic knowledge of regulatory guidance documents such as ICH guidance
- Experience in developing clinical trial protocols
- Experience producing clinical biostatistics top line reports
- Ability to provide critical input to the statistical lead or team in optimizing study or trial designs in line with study or trial objectives
- Ability to support scenario simulations and sample size calculations based on relevant technical and disease/scientific/functional area knowledge
- Good written, oral, and interpersonal communication skills
- Ability to work independently
- Ability to provide guidance, oversight and review of work performed by External Service Providers
- Ability to work effectively in a multidisciplinary team environment
- Fluency in English, both written and spoken
What’s in it for you…?
“Caring for the world, one person at a time…”
As an employee we consider you as our most valuable asset. We take your career seriously.
As part of a global team in an innovative environment your development is key and our day-to-day responsibility. Through e-university, on the job training, various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future
Janssen Pharmaceutica N.V. (7555)