Senior Biostatistician

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Job description

Biosense Webster, Inc., a division of Johnson & Johnson's Family of Companies is recruiting a Senior Biostatistician to be located in Irvine, California.

At Biosense Webster, Inc. we have one goal - to ensure those with cardiac arrhythmias can live the lives they want. This means transforming the latest advancements in electrophysiology into a suite of tools that empowers physicians with a range of treatments for the best outcomes.

Quality products and approaches are achievable only through collaboration with the smartest minds in electrophysiology. For more than 30 years, we've been the global market leader in the science and technology of cardiac arrhythmia treatment, working with thousands of electrophysiologists to identify and develop diagnostic and treatment tools. And through onsite training, online courses and our global education centers, we work together to set new standards every day.

Learn more about Biosense Webster at and follow us on LinkedIn .

Job Description:

The Senior Biostatistician will be responsible for designing statistical analysis plans for clinical studies; performing statistical analyses independently; creating reports intended for internal distribution and for regulatory submission; creating internal presentations and white papers; and interfacing with surgeons to assist in drafting peer-reviewed journal articles. His/her work will follow guidance from Biostatistics management, and will adhere to applicable regulations for pre- and post market clinical trials. S/he ensures statistical analyses are conducted with the highest level of scientific integrity, while meeting timelines and budgets. Reporting to the Biostatistics Manager.

Primary responsibilities:

• Interact with Biostatistics, Data Management, Regulatory, and Clinical staff to define and clarify project requirements.
• Design and execute statistical plans for all phases of clinical studies of moderate complexity under limited supervision.
• Review clinical study protocols and Case Report Forms (CRFs) for proposed studies with respect to statistical methodology.
• Generate randomization schemes; unblind treatment assignments and handle unblinded information appropriately.
• Support 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.
• Contribute to peer-reviewed articles independently, in coordination with the lead author/physician.
• 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 (e.g., statistical power analysis).
• Assist in the preparation and documentation of results to support trial reports and publications.
• Resolve complex statistical issues from business units and external customers.
• Provide statistical reports for data quality/performance metrics.
• Assist Clinical Research with literature reviews and other activities.
• May assist in preparing information and materials for presentation at professional meetings.
• Stay current with statistical methodology in clinical trial design and analysis.

Qualifications

• Demonstrated technical experience in preparing statistical deliverables on time.
• Thorough understanding of descriptive statistics, hypothesis testing, non-parametric, and multivariate statistical tests.
• Ability to assist in selecting and applying methods and analyses in the field of application.
• Understand the processes involved in strategic planning.
• Experience with survival analysis, longitudinal data analysis, and other current, innovative statistical methodologies.
• Excellent verbal and written communication skills.
• Knowledge of Microsoft packages; PowerPoint, Excel, Word.
• Proficient in SAS. Familiarity with other statistical packages for handling smaller datasets and power analyses.

Education & experience requirements:

• Master's degree or Ph.D in Statistics.
• At least 4 years of experience (or Ph.D. with 2 years) performing statistical analyses in a regulated environment, preferably medically related including FDA, GCP or other relevant area.

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

Primary Location
United States-California-Irvine-31 Technology Dr
Organization
Biosense Webster Inc. (6010)
Job Function
R&D
Requisition ID
W