Janssen Pharmaceuticals, Inc, a member of Johnson & Johnson's Family of Companies, is recruiting for a Principal Statistician to be located in Raritan, NJ and may require up to 15% both domestic and international travel.
Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including in oncology, immunology, neuroscience, infectious disease, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency. Please visit http://www.JanssenRnD.com for more information.
The Principal Statistician supports the design, execution, analysis, interpretation, and reporting or communication of data evidence for Early/Late Clinical Development programs for research, development, and/or marketed product needs in Janssen, with minimal supervision. This position supports statistical aspects of business-critical and/or regulatory commitments, provides input to program plans with limited supervision, and represents Statistics & Decision Sciences (SDS) for cross-functional and intra-departmental teams or working groups. The disease area that is targeted is oncology with a focus on: hematologic malignancies, prostate cancer and lung cancer; cancer interception with the goal of developing products that interrupt the carcinogenic process
The Principal Statistician will:
- Demonstrate advanced data analytic expertise based on a foundation of statistical principles and a strong track record of applied experience leading to successful program support.
- Effectively use relevant computational tools for study, experiment, or trial research objectives.
- Apply high quality statistical methodology in assigned projects with demonstrated understanding of the disease/scientific/functional area and health authority acceptability.
- Comply with organization and company standard operating procedures in timely fashion, such as training and project time accounting.
- Contribute high quality and timely deliverables as assessed by stakeholders such as the project team, the clinical trial team, and the Statistics Area Head.
- Ensure that documents, specifications, programs, and macros are consistent and comply with project and company standards.
- Follows best practices for Data Integrity.
- Take the lead in providing SDS support to experimental design, modeling, analysis planning, analysis execution, interpretation, and statistical communications.
- Performs the evaluation of alternative or innovative approaches to statistical methods or business processes in complex program
- Accountable for execution of individual project responsibilities, including: meetings with necessary project team members, reporting activities, exploratory analyses/graphics, and additional analyses to support publications for individual clinical trials/studies/projects.
- Builds cross-functional partnerships with internal colleagues and with external partners (e.g. Contract Research Organizations (CROs), consultants) to achieve results for project specific needs.
- Ph.D. in Statistics or related field with minimum 3 years relevant experience, or Master’s in Statistics or related field with a minimum 5 years of relevant experience.
- Proficiency in SAS or R, as well as a working knowledge of other relevant computational tools is strongly required.
- Ability to work in a matrix organization and cross-functionally to identify and resolve issues is required.
- Experience with planning, running, and documenting simulations (including, but not limited to clinical trial simulations) is preferred.
- Strong written, oral and interpersonal communication skills.
- Demonstrated ability to collaborate and consult with non-statisticians, translating complex statistical concepts to drug research & development partners is required.
United States-New Jersey-RaritanOrganization
Janssen Research & Development, LLC. (6084)Job Function