Employer: Biosense Webster, Inc. Job Title: Senior Biostatistician Job Code: A011.4436 Job Location: Irvine, CA Job Type: Full-Time Rate of Pay: $ 120,000 - $ 145,000 Job Duties: Evaluate statistical and analytical services in support of clinical trials, regulatory submissions, and quality initiatives. Ensure statistical analyses are conducted with the highest level of scientific integrity, while meeting timelines and budgets. Provide guidance on standards, processes, and technical topics within the statistics team. Adhere to applicable regulations for pre- and post-market clinical trials under guidance from Biostatistics management Work 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. Assist with preparation of documentation for IRB/Ethics Committee submissions, such as statistical power analysis. Act as a statistical consultant to the business units on statistical issues. Provide oversight for statistical and programming deliverables produced by external vendors. Provide statistical reports for data quality/performance metrics. Assist Clinical Research with literature reviews and other activities. Stay current with statistical methodology in clinical trial design and analysis. Requirements: Employer will accept a Ph.D. degree in Statistics or related field and 3 months of experience in the job offered or in a Senior Biostatistician-related occupation .
This job posting is anticipated to close on 5/12/2024. The Company may however extend this time-period, in which case the posting will remain available on to accept additional applications.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program.
Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year Holiday pay, including Floating Holidays - up to 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below.
For additional general information on Company benefits, please go to: -
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.
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