LEAD CLINICAL BIOSTATISTICIAN
- Irvine, CA
The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting for a Lead Clinical Biostatistician, to be located in in Irvine, CA.
The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.
The CSS Group consists of five diverse businesses including Acclarent, Biosense Webster, Cerenovus, Mentor, and Sterilmed. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Electrophysiology, Surgical and Non-Surgical Aesthetics, Neurovascular, and Reprocessing and is committed to delivering innovative products, solutions and programs to address unmet customer and patient needs around the world.
The Lead Biostatistician will be primarily responsible for the statistical design and analysis of clinical and observational studies in support of Johnson & Johnson's Cardiovascular & Specialty Solutions (CSS) Group.
The Lead Biostatistician will:
- Work closely with clinical teams in designing clinical studies, leading/authoring the statistical analysis plan, conducting the statistical analysis, and providing statistical input to the clinical study report. Interact with Biostatistics, Data Management, Regulatory, and Clinical staff to define and deliver project requirements. Design and execute statistical plans for different phases of clinical studies independently, assuming a leadership role in creating strategy for study design and analyses. Perform and interpret exploratory statistical analyses in support of CSS devices. Produce statistical reports that may be incorporated into internal clinical reports or regulatory submissions. Review clinical study protocols, clinical study reports, and publications with respect to statistical methodology. Review articles on topics relevant to specified products and provide reports concerning issues relating to statistical methodology. Oversee production of presentation materials for professional meetings and may assist in presenting information at these meetings.
- Master's degree (PhD preferred) in Statistics or Biostatistics required At least 6 years of experience (or 4 years with a PhD) in clinical research within Medical Device or Pharmaceutical industries required Knowledge of statistical methods for clinical trials required Thorough understanding of statistical inference preferred Experience with statistical modeling for continuous and categorical data, survival analysis, longitudinal data analysis, and other statistical methodologies required Knowledge of statistical methods for observational studies Proficiency in SAS and/or R statistical software required Excellent verbal and written communication skills Knowledge of Microsoft packages; PowerPoint, Excel, Word
Biosense Webster Inc. (6010)
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