Copy Of Senior Research Statistician (Immunology)(On-Site)

Job Description
Description:
Medical Affairs and Health Technology Assessment (MA&
HTA) Statistics is responsible for partnering with AbbVie MA and other corporate functions to provide expertise in biostatistics and mathematics. The partnership is realized in the context of a cross-functional, product-oriented effort to provide statistical expertise and consultation for all key MA business activities, including but are not limited to MA research proposal reviews, strategic planning and input on TA strategies, real world evidence (RWE) study designs, real world database (RWD) research, scientific presentations and publications for all therapeutic areas, vendor oversight of study executions, RWE methodology research, and evidence evaluations and generations. In addition, this role may also support HTA supporting market access and reimbursement.
Major Responsibilities:
Provide statistical expertise for design, analysis and reporting of clinical or other scientific research studies and contribute to development of modern program/trial design methodologies with a focus on RWE gathering, analysis and interpretation. Compliant with applicable corporate and divisional policies, procedures, and cultural values.
Assist with the development of scientific protocols including statistical analysis plan (SAP), ensuring they are scientifically sound, aligned with the product strategy, and meet scientific and/or applicable regulatory needs. Ensure statistical methodology is appropriate and sound, consistent with the objective(s) of the scientific investigations.
Demonstrate excellent understanding of statistical concepts and methodologies. Take a leadership role in introducing new/novel statistical methodological approaches into analysis plans which improve the efficiency and validity of study results. Be able to explain statistical concepts to non-statisticians.
Review identified or anticipated technical or data related issues arising in the design, conduct, and analysis of clinical trials and other scientific research. Assist with proposing and implementing alternative analysis strategies or other recommendations to address these issues. Evaluate appropriateness of available software for planned analyses and assess needs for potential development of novel statistical methodology.
Maintain technical skills and increase own knowledge of new statistical methodology or areas of application through scientific literature and attendance at professional meetings. Present own statistical research or review of the statistical literature at meetings and seminars. Demonstrate a high degree of responsibility in maintaining Statistics department standards, GxP compliance, and best operating practices.
In collaboration with MA, Clinical Statistics, Data Sciences, Statistical Programming and other stakeholders to evaluate existing databases, both clinical studies and real-world databases, conduct feasibility assessment to identify fit-for-purpose data sources to address research questions, and develop detailed and actionable analysis plans for evidence generation to deliver high quality, patient-centric evidence and insights to drive decisions.
Ensure that study results and conclusions are scientifically sound, clearly presented, and consistent with statistical analyses provided. Ensure timely and quality statistical deliverables. Assist with addressing questions at management and/or product review meetings. Provide in-depth scientific/statistical review for scientific reports and publications. Ensure the accuracy of the statistical component of scientific reports and/or publications with high quality.
Support MA Statistics group in partnership with MA, Clinical Research and Clinical Statistics to develop scientifically appropriate strategies for evidence generation, including MA studies, presentations, and publications in assigned therapeutic area(s). Support MA Statistics to provide functional area input for life cycle management of products. Support communications between assigned product team(s) and functional management. Build/drive cross-functional relationships and collaboration.
Support HTA submissions.
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required