Senior Statistician, Clinical Biostatistics, Late Phase Development
Janssen Pharmaceutical Companies part of the Johnson & Johnson Family of Companies is recruiting for a Senior Statistician to be located in Titusville, NJ, Spring House, PA, or Raritan, NJ.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC. is part of the Janssen Pharmaceutical Companies.
You, the Senior Statistician provides statistical services including analysis, interpretation, design, and reporting or communication of data evidence for research, development, and/or marketed product needs in Janssen. This position supports statistical aspects of business-critical and/or regulatory commitments. Responsibilities include:
- Expertise: Demonstrates advanced data analytic expertise based on a foundation of statistical principles and a track record of applied experience. Is effective in the use of relevant computational tools for study, experiment, or trial research objectives. Applies high quality statistical methodology in assigned projects with demonstrated understanding of the disease/scientific/functional area and health authority acceptability. Ensures application of appropriate statistical methods and generation of accurate and reproducible results working independently or by providing specifications to statistical programming colleagues. Produces clear, concise, well-organized, and error-free computer programs and statistical reporting content.
- Quality and Compliance: Complies with organization and company standard operating procedures in timely fashion, such as training and project time accounting. Understands and aligns with relevant regulatory guidance's. Contributes high quality and timely deliverables as assessed by stakeholders such as the project team, the clinical trial team, and the Statistics Area Head. Ensures that documents, specifications, programs, and macros are consistent and comply with project and company standards. Follows best practices for Data Integrity.
- Drug Development: Acquires and demonstrates knowledge in pharmaceutical research and development strategies and execution. Assists in providing experimental design, modeling, analysis planning, analysis execution, interpretation, and statistical communications support. Is 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. Provides critical input to the statistical lead or team in optimizing study or trial designs in line with study or trial objectives and supports scenario simulations and sample size calculations based on relevant technical and disease/scientific/functional area knowledge.
- Collaboration: Establishes and maintains effective and efficient interfaces and relationships with internal and external customers, with support of Statistics & Decision Sciences (SDS) management. Routinely contributes to area (e.g. discovery, translational, early development, late development) project meetings. Contributes positively to SDS team dynamics with a clear understanding of the SDS vision.
- Programming: Demonstrates full proficiency in SAS or R, as well as a working knowledge of other relevant computational tools as required.
- Process: Deep knowledge of data architecture, such as Data Standards. Recognizes the need and value of process standardization.
- External Engagement: Participates as a member of professional organizations, such as attending meetings sponsored by professional organizations.
- A Ph.D. in Statistics or related field OR a Master's Degree in Statistics or related field with a minimum of six (6) years of relevant experience. Consideration will be given to candidates with documentation indicating that the all of the requirements for the Ph.D. have been met prior to the start date is required
- A basic understanding of design & analysis of clinical trials is preferred
- Basic knowledge of SAS or R programming is required
- Strong written, oral, and interpersonal communication skills are required
- This position may require up to 10% domestic and international travel.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability
United States-New Jersey-Raritan-
North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Spring House
Janssen Research & Development, LLC (6084)
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