Assistant Site Controller

Senior Statistical Analyst (Eye Care | Aesthetics), AbbVie Inc., Irvine, CA: Hybrid (onsite 3 days a week/ 2 days WFH). Deliver statistical programming expertise for clinical studies with lower complexity. Ensure accurate data analysis, reporting, & adherence to regulatory standards. Develop SAS programs for generating ADaM datasets, tables, listings, & figures. Create specifications for ADaM datasets for individual & integrated analyses. Collaborate closely with crossfunctional teams to achieve project objectives. Prepare documentation for regulatory submissions, including reviewers guides & data definition documents. Lead development of standard SAS macros & participate in development of standard operating procedures. Provide supervision & mentorship to statistical programmers & analysts. Must have a MS in statistics, biostatistics, computer science, mechanical engineering or a related field & 2 years as a statistical analyst leading statistical programming activities for clinical studies. Of experience required, must have 2 years: (i) applying SAS programming concepts & techniques related to drug development; (ii) creating & validating ADaM datasets in compliance with CDISC/ADaM Standards; (iii) providing statistical programming supporting for Phase I, II, & III clinical trials; (iv) generating clinical outputs (tables, listings, & figures) with SAS; & (v) utilizing each of the following SAS tools: SAS/BASE, SAS/MACROS, SAS/SQL, SAS/GRAPH, & SAS/STAT. Alternatively, would accept a BS in statistics, biostatistics, Computer science, mechanical engineering or a related field & 5 years as a statistical analyst leading statistical programming activities for clinical studies. Of experience required, must have 5 years: (i) applying SAS programming concepts & techniques related to drug development; (ii) creating & validating ADaM datasets in compliance with CDISC/ADaM Standards; (iii) providing statistical programming supporting for Phase I, II, & III clinical trials; (iv) generating clinical outputs (tables, listings, & figures) with SAS; & (v) utilizing each of the following SAS tools: SAS/BASE, SAS/MACROS, SAS/SQL, SAS/GRAPH, & SAS/STAT. Work experience may be gained concurrently. Will accept reasonable combination of education, training & experience. Salary Range: $146,467.84 - $183,500.00 per year. Apply online at https://careers.abbvie.com/en or send resume to Job.opportunity.abbvie@abbvie.com. Refer to Req ID: REF49786C.
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