Remote, 12-month contract with potential to extend
As an embedded member of the Clinical Data Sciences – Real-World Evidence (CDS-RWE) Analytics group, the Associate Director, RWD (PRO) Analyst reports directly to the Head of RWE Analytics and indirectly into the Sr. Director, Global Value & Access (GV&A) – Center of Excellence – HEOR Analytics. The incumbent will design and conduct statistical analyses of PRO data from clinical trials and real world data sources to assess the value of therapies from the patient perspective. Additionally, the incumbent will interpret and communicate PRO results to internal stakeholders in GV&A. The Associate Director will align with Digital Innovation, Clinical Data Sciences, Health Economics and Outcomes Research (HEOR) scientists to conduct timely, relevant and rigorous analysis of PRO data to address critical research questions, as well as collaborate with epidemiologists and other scientists to develop, refine, and scale data management and analytics procedures, systems, workflows, best practices, and other issues.
- Conduct analyses and develop specifications for descriptive and complex statistics in studies with PROs for HEOR research questions including impact of treatment from the patient perspective, patient reported burden of disease, patient perspective of disease progression and effectiveness.
- Collaborate on study protocols and statistical analysis plans of PRO endpoints in clinical trials
- Conduct analyses to inform PRO parameters for economic models (e.g. utility).
- Conduct validation and post-hoc analyses of patient reported outcomes.
- Develop content and psychometric validation plans for PRO endpoints in clinical trials
- In collaboration with HEOR leads select appropriate internal database to address research questions.
- Develop reports/manuscripts from RWE research conducted to assess the value of therapies using RWD (e.g. claims and EHR).
- Work with epidemiologists and HEOR scientists to generate code lists for new measures in RWD.
- Write SAP for descriptive and complex studies in RWD, including claims and EHR.
Knowledge, Skills and Experience
- Master’s degree (e.g. MA, MSc, MPH) in Biostatistics, Epidemiology, Health Services Researchers, Pharmaceutical Economics and Policy, or related discipline, such as Outcomes Research from an accredited institution, with a minimum of seven (7) years of relevant, post-graduation experience; doctoral level training is preferred. Direct experience in lieu of academic training is acceptable.
- Knowledge of PRO data and experience in clinical and observational research study design, execution and communication.
- Understanding of the analysis of PRO data for regulatory approval
- Understanding of analysis of PRO data to inform economic models
- Understanding of the quantitative validation of patient reported outcomes
- Strong track record of analysis of PRO data from clinical trials and RWD.
- Formal training in Programming and demonstrated proficiency in statistical analysis programs commonly used in life sciences (e.g. SAS, R).
- Understanding of epidemiology, outcomes research, and policy research and the application of retrospective or prospective studies to generate value evidence.
- Ability to work effectively in a constantly changing, diverse, and matrix environment.
- Knowledge of US secondary data sources required; additional experience with international data sources is preferred.
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