Manager, Statistics #REF23815C - Costa Mesa California

Company: Confidential
Location: Costa Mesa, California
Posted On: 05/04/2024

Manager, Statistics, AbbVie Inc., Irvine, CA. Responsible for the design, analysis & reporting of clinical trials or other scientific research studies. Apply statistical techniques to facilitate better decision-making & improve business operation. Regularly interact with management of different levels in strategy meetings. Contribute to strategic planning to ensure statistically optimized non-clinical development plans and assist in the creation of strategic objectives for regulatory filings. Participate in the planning/ design, conduct, analysis, and interpretation of non-clinical studies & regulatory submissions. Collaborate with colleagues from other departments to ensure compliance with regulations & help implement regulatory initiatives such as Quality by Design & process validation. Participate in establishing departmental and non-clinical SOPs & guidelines. Develop statistical tools to streamline process development, QC testing & troubleshooting. Prepare statistical courses & provide training for scientists. Develop & deliver statistical & scientific publications & present internally & externally. Collaborate with other statisticians in improving & sharing statistical approaches. Develop protocols & statistical analysis plans or product safety analysis plans, integrated summary of safety analysis plans, & analysis plans for GMA evidence generation with details for programming implementation. Implement statistical methodology in scientific investigations & identify scientifically appropriate data collection instruments. Identify & report data issues or violations of study assumptions & provide programming specifications for derived variables & analysis datasets. Identify & anticipate issues arising in the study design, conduct & propose scientifically sound approaches. Evaluate appropriateness of available software for planned analyses & assess needs for potential development of novel statistical methodology. Ensure accuracy & internal consistency of reports & publications, including tables, listings, & figures utilizing statistical software such as SAS & R. Ensure that study results & conclusions are scientifically sound, clearly presented, & consistent with statistical analyses provided. Provide responses to questions, & pursue analyses suggested by data. Collaborate with cross functional team for benefit-risk planning & assessment. Contribute to cross-functional development of output specifications to address both pre-planned safety analyses & ad hoc requests. Collaborate/lead within the Safety Statistics Group to implement strategic initiatives that address processes related to interpreting, monitoring, assessing, & reporting safety data to characterize the safety profile of organizational products, improve efficiencies, & provide consistency across therapeutic areas.
Must have a Master's degree or foreign academic equivalent in Statistics, Biostatistics, or a highly related field of study with at least 3 years of related experience in the following: (i) Design in analysis & reporting of clinical trials or other scientific research studies; (ii) participating in the planning/design, conduct, analysis, & interpretation of non-clinical studies & regulatory submissions; (iii) developing protocols & statistical analysis plans or product safety analysis plans, integrated summary of safety analysis plans, & analysis plans for GMA evidence generation with details for programming implementation; & (iv) ensuring accuracy and internal consistency of reports & publications, including tables, listings, & figures utilizing statistical software such as SAS & R. Salary Range: $158,204 - $201,000 per year.
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