Manager, Statistics - Irvine, United States - AbbVie
Description
Company Description
Job Description Key Responsibilities**- Responsible for the design, analysis & reporting of clinical trials or other scientific research studies.
- Regularly interact with management of different levels in strategy meetings.
- Contribute to strategic planning to ensure statistically optimized nonclinical development plans and assist in the creation of strategic objectives for regulatory filings.
- Participate in the planning/design, conduct, analysis, and interpretation of nonclinical 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 nonclinical 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 benefitrisk planning & assessment.
- Contribute to crossfunctional development of output specifications to address both preplanned 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.
Qualifications
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:
- Design in analysis & reporting of clinical trials or other scientific research studies;
- 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; &
- 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
Additional Information
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term and long-term incentive programs.More jobs from AbbVie
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