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 Programmer/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 RWE from clinical trials and real world data sources to assess the value of therapies. Additionally, the incumbent will interpret and communicate RWE 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 clinical trail and RWD 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 RWE 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 RWE endpoints in clinical trials
- Conduct analyses to inform RWE parameters for economic models (e.g. utility).
- Conduct validation and post-hoc analyses of patient reported outcomes.
- Develop content and psychometric validation plans for RWE 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 RWD and experience in clinical and observational research study design, execution and communication.
- Understanding of the analysis of RWD for regulatory approval
- Understanding of analysis of RWD to inform economic models
- Understanding of the quantitative validation of patient reported outcomes
- Strong track record of analysis of RWE 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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