Johnson & Johnson Careers
Warsaw, Indiana; West Chester, Pennsylvania; Raynham, Massachusetts
Requisition ID: 2364190711
The Johnson and Johnson Medical Device (MD) Sector is recruiting for a Lead Biostatistician to support clinical research. Locations for this position are West Chester, PA, Warsaw, IN, or Raynham, MA.
The MD clinical research organization has three interactive teams: Clinical, Operations, and Biostatistics & Data Management. All three teams share accountability for the successful development and delivery of clinical evidence that drives innovation in surgical solutions and that optimizes the product lifecycle.
The Lead Biostatistician will be responsible for leading statistical and analytical services in support of clinical trials, regulatory submissions, marketing efforts, and quality initiatives, as well as providing guidance on standards, processes, and technical topics within the statistics team. Your work will adhere to applicable regulations for pre- and post- market clinical trials. You will ensure statistical analyses are conducted with the highest level of scientific integrity, while meeting timelines and budgets. Responsibilities include:
- Provide guidance on standards, processes, and technical direction within the biostatistics team.
- Interact with Biostatistics, Data Management, Regulatory, and Clinical staff to define and clarify project requirements.
- Design and execute statistical plans independently for all phases of clinical studies, assuming a leadership role in creating strategy for study design and analyses.
- Review clinical study protocols and Case Report Forms (CRFs) for proposed studies with respect to statistical methodology.
- Supervise generation of randomization schemes; supervise unblinding of treatment assignments and appropriate handling of unblinded information.
- Lead the review and assessment of protocol deviations to the extent that they affect statistical analyses.
- Produce statistical reports that may be incorporated into internal clinical reports or regulatory submissions.
- Review articles on topics relevant to specified products and provide reports concerning issues relating to statistical methodology.
- Assist with preparation of documentation for IRB/Ethics Committee submissions.
- Act as a statistical consultant to the business units and external customers on statistical issues.
- Assist in the preparation and documentation of results to support trial reports and publications.
- Participate in vendor evaluation, selection, contracting, and oversight for statistical and programming deliverables.
- Provide statistical reports for data quality/performance metrics.
- Assist Clinical Research with literature reviews and other activities.
- May assist in presenting information at professional meetings.
- May oversee production of presentation materials for presentations at professional meetings.
Master’s degree in Statistics, Biostatistics, or Applied Mathematics with at least 6 years of experience OR a Ph.D. with at least 4 years of experience performing statistical analyses in a regulated environment, preferably medically related including FDA, GCP or other relevant area are required.
• Thorough understanding of descriptive statistics, power/sample size analysis, hypothesis testing, non-parametric, and multivariate statistical tests is required.
• Experience with survival analysis, general linear models, logistic regression, covariate adjusted analyses, and other current, innovative statistical methodologies is required.
• Knowledge of Bayesian statistics OR meta-analyses is preferred
• Excellent verbal and written communication skills is required
• Proficiency in SAS is required
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
North America-United States-Pennsylvania-West Chester, North America-United States-Massachusetts-Raynham
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