Biostatistician

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Job description

Biosense Webster, Inc., a division of Johnson & Johnson's Family of Companies is recruiting a 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.

Overall responsibilities:

The Biostatistician will be responsible for designing statistical analysis plans for clinical studies; performing statistical analyses; contributing to reports and supporting statistical analytical services in support of clinical trials, regulatory submissions, marketing efforts, quality initiatives, and internal presentations. 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.

Key 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 limited complexity
* 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
* Produce statistical reports that may be incorporated into internal clinical reports or regulatory submissions
* Assist in the preparation and documentation of results to support trial reports and publications
* Provide statistical reports for data quality/performance metrics
* Stay current with statistical methodology in clinical trial design and analysis

Functional and Technical Competencies:

* Demonstrated technical experience in preparing statistical deliverables on time.
* Thorough understanding of descriptive statistics, hypothesis testing, non-parametric, and multivariate statistical tests.
* Knowledege of survival analysis, longitudinal data analysis, and other current, innovative statistical methodologies is preferred.
* Excellent verbal and written communication skills.
* Knowledge of Microsoft packages; PowerPoint, Excel, Word.
* Proficient in SAS and/or R.

Qualifications

Education & experience requirements:

* A Bachelor's or Master's Degree in Statistics.
* At least 4 years of experience (or Master's with 0 to 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-33 Technology Drive

Organization

Biosense Webster Inc. (6010)

Job Function

R&D

Requisition ID

W