We are seeking a Research Scientist for a 2-year regular position (renewable) at the International Vaccine Institute in Seoul, Korea to work within the Epidemiology, Public Health, Impact, Clinical Development Unit.
This position is responsible for providing strategic and statistical input for the program development and coordinate the study design, statistical analysis and reporting of multiple complex studies. It also reviews and evaluates statistical methodologies and data analysis of the IVI’s research programs. This position oversees and provides guidance in the development and maintenance of the data systems while contributing to the development and maintenance of standard operating procedures (SOPs) and template.
Main Roles & Responsibilities:
- Provide strategic and statistical input in the plan and execution of studies in IVI research program as a study lead statistician
- Collaborate in study design and propose analytical methods including sample size calculation for the epidemiological and clinical researches.
- Contribute and evaluate study concept note, study protocols, the clinical trial design, and the case report forms and other data documents and provide inputs to ensure that the research programs are implemented to meet project objectives.
- Develop statistical analysis plan and randomization process.
- Lead and oversee all data management activities and statistical activities in the study.
- Collaborate and interact with other project Lead to ensure for successful execution of projects.
- Prepare documents for the analysis result and provide statistical interpretation of data to CSR (clinical study report) and other regulatory documents.
- Discuss and address for the solutions to statistical problems.
- Analyze study data using advanced statistical methods
- Stay abreast of latest development in the field of statistics, contribute to scientific advances in the field and apply new technologies in the daily activities.
- Review statistical method section of the manuscripts and interpretation of the outcomes of the statistical analysis.
- Publish applied research in scientific journal and books and give presentation on statistical ( or related) method in professional field.
- Develop geographical methods, prepare analytical dataset and apply the methods in geo-coded data to conduct the analysis.
- Lead design and maintain the library of data management (DM) system
- Collaborate with DM team for the development and validation of the library of computerized data systems according to ICH/GCP and FDA guidelines to develop the data systems for each study in IVI research program in an appropriate platform.
- Consult with DM lead for each study regarding the preparation of users’ manual and training of data staff at the study site.
- Lead and /or participate in the development and review of policies, SOPs and other controlled document
Job Requirements and Qualifications:
- Education Requirements
- Master’s degree in statistics or biostatistics or equivalent Ph.D.
- Related Field Work Experience
- Ph.D.: 6+ years in the related field
- Master’s degree: 12+ year of experience in the related field
- Technical and Professional Skills / Knowledge
- Knowledge in Clinical Trial or Epidemiology
- Proficiency in statistical methodology and data management principal
- Knowledge of computer programming languages (web application and database)
- Strong understanding of guidelines in relevant research setting
- Language Proficiency
- Fluency in English