Medical Affairs & Health Technology Assessment (MA&HTA) Statistics is responsible for partnering with AbbVie Medical Affairs & Health Impact (MHI), international Market Access and Pricing (iMAP), 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 MHI or HTA business activities, including but are not limited to Medical Affairs 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 for HTA submissions.
Major Job Responsibilities
- Provide scientific and statistical expertise through own efforts and those of her/his staff (if appropriate) for drug development and life-cycle management strategies for assigned projects; for the design, analysis, and reporting of clinical and other scientific research programs; for generating scientific evidence to support medical affairs strategies; and for interacting with regulatory agencies, medical community, and key opinion leaders (KOLs) regarding the results of these activities.
- Direct the development of scientific protocols, 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 an 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 or analysis of clinical trials or other scientific research. Independently select, evaluate and implement alternative analysis strategies or other recommendations to address these issues. Evaluate appropriateness of available software for planned analyses and assess needs for potential program 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. Demonstrates a high degree of responsibility in maintaining Statistics department standards, GxP compliance, and best operating practices.
- In collaboration with MHI, 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 for research questions, and develop detailed and actionable analysis plans for evidence generation to deliver high quality, patient-centric evidence and insights to drive decisions.
- Evaluate alternatives to traditional randomized clinical trials that make use of real-world databases, e.g. electronic health records, insurance claims databases, and/or registries.
- Play a key role in the cross-functional team and ensure that study results and conclusions are scientifically sound, clearly presented, and consistent with the statistical analyses provided. Ensure timely and quality statistical deliverables. Assist other MA&HTA Statistics colleagues or represent MA&HTA Statistics in 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/Lead HTA submission for optimal reimbursement and product life-cycle management strategy planning and implementation for assigned projects/indications. Provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs. Independently develop protocols and statistical analysis plans to fulfil the evidence gaps.