Job Information
AbbVie Manager, Statistics in Irvine, California
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X (https://twitter.com/abbvieireland) , Facebook, Instagram (https://www.instagram.com/abbvieireland/) , YouTube and LinkedIn.
Job Description
Key Responsibilities
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.
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;
participating in the planning/design, conduct, analysis, & interpretation of non-clinical studies & regulatory submissions;
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
Apply online at https://careers.abbvie.com/en. Refer to Req ID: REF23815C.
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.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.