Senior Biostatistician
Company: Disability Solutions
Location: Irvine
Posted on: May 9, 2024
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Job Description:
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.
Keywords: Disability Solutions, Placentia , Senior Biostatistician, Other , Irvine, California
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