Health Economics & Outcomes Research (HEOR) Consultant, will be responsible for all statistical aspects of research conducted by the HEOR function, such as statistical input into study design, the analysis and reporting plan, and the analysis and interpretation of results. This person will work independently and as part of a multifunctional team and lead or contribute to the development of a final statistical analysis plan (SAP), tables and listing shells. The Biostatistician will also provide statistical expertise to the designated in-house departmental and corporate projects and initiatives.
Key Responsibilities:
•Provides analytical and methodological expertise on studies for the HEOR function
•Evaluate and explore the implementation of innovative statistical methods in support of HEOR research
•Provide analytical and statistical support on HEOR research performed within claims data, EMR data, clinical trial data, and registry data
•Provide statistical contributions, statistical review and quality control of protocols, analysis plans, table, figure, and listing shells, database specifications, other key-study related documentation
•Ensure timeliness and adequate quality for all deliverables for the assigned tasks
•Work closely with HEOR principals to design HEOR studies to select the appropriate data (e.g., eCRF design, database design, registry data)
•Contribute to analysis sections in manuscripts and publications
•Provide statistical analysis of individual study/projects using SAS and/or other suitable software
•Interface with members of the HEOR study teams
•May contribute to strategy on signal detection capabilities for use in the analysis of pre-marketing and post-marketing adverse event databases, quantitative analysis of product benefit-risk profiles
•May contribute analytical statistical support to clinical trials conducted in Clinical Research
•Work collaboratively within and across project teams
•Serve as a subject matter expert in own field within the department and broader organization
Minimum Basic Qualifications:
•PhD/MSc. in Statistics, Mathematics, Epidemiology or related field with a substantial statistical component
•7 years of relevant experience including 5 years working as a statistician within the pharmaceutical industry
•Have a good data analysis and computer programming skills in advanced statistical software packages, e.g., SAS, SPSS
•Comprehensive understanding of clinical development strategies and trial designs
•Have a good organizational skills of own work load with the ability to adapt and adjust to changing profiles
•Expert analytical skills
•Experience with claims and EMR data
•Excellent written and oral communication skills and ability to build strong relationships
•Ability to work collaboratively with colleagues and project leads for the good of the business overall.
•Aptitude for attention to detail.
•Expert ability to compile, analyze and present data in a clear and concise manner.
•Ability to prioritize and effectively manage several projects simultaneously.
Preferred Qualifications and Experience:
• Experience with Health Economics/Payer Analytics deliverables and techniques, and with the role of statistics in optimizing those deliverables
• Systematic literature review and synthesis of clinical evidence from both trials and observational data sources, including the use of Bayesian techniques, e.g., meta-analysis, indirect and mixed treatment comparisons
• Modeling and extrapolation of clinical trials data to the real world setting e.g., extrapolation of time-to-event curves, accounting for the impact of treatment switch (crossover)
• Analyses of patient reported outcomes and patient preferences of health states
• Excellent process and project management skills required including the ability to manage a significant volume of projects with exercise of good triage and judgment skills
• Strong knowledge of regulatory and commercial compliance issues relating to conducting research and disseminating of scientific information is required.