EDC Programmer Analyst
Informatics | San Francisco, Ca | Full Time
Overview of the Role
The EDC Programmer Analyst is a subject-matter expert on study design, configuration, and testing, utilizing off-the-shelf systems such as Medidata Rave and REDCap. Using Medidata RaveX, along with the Balance and Coder modules, this individual is responsible for all aspects of EDC design and study build in immune-oncology studies.
Working closely with the Clinical Operations team, the EDC Programmer Analyst will help to design and implement the eCRFs. While following best practices in creating the studies, this individual will need to ensure proper design standards and understand all reporting. The EDC Programmer Analyst will also verify creation and validation of reports using JReview and BO4/BOXi.
Reporting Structure and Team
The EDC Programmer Analyst reports to the Executive Director Technology and is a key member of the Informatics team.
Essential Job Functions
- EDC programmer and business analyst working on designing and supporting CRFs
- Proven ability to produce standard clinical study reports
- Develop, program, test and maintain study databases including data entry screens, edit checks and Lab Values
- Review and update lab-values, edit-checks across multiple studies
- Review and validate peer development
- Support in-house data management team (SME and technical expert)
- Perform data validations and data extracts, as needed, for statistical analysis and reporting
- Interact with other cross-functional teams
- Monitor and report the progress of study-design in a timely manner
Knowledge, Skills, and Experience
- 5+ years of working as an EDC programmer and/or business analyst
- 4-6 years of Industry or academia experience in running early phase clinical trials
- BS/BA degree, or equivalent, in a related scientific discipline
- Experience in Medidata Rave or RaveX is a MUST
- Advanced knowledge of clinical database design using RAVE
- Knowledge in more than one EDC system is a PLUS
- Good communication skills, ability to work in a team environment with data managers, medical personnel, clinical monitors, statisticians and programmers
- Knowledge of FDA/ICH guidelines and industry standard practices regarding programming
- Detailed knowledge and experience in case report form design, form annotations, central and local laboratories, query resolution and data validation
- Good command of clinical database design and specification review
- Serve as an expert on technical issues in EDC systems
- Provide general and study-specific EDC training as needed
- Provide technical support, as appropriate, for system integrations with third party tools such as IxRS.
- Exposure to CDISC and CDASH standards
- Develop and validate technical programming specifications for transforming raw data into SDTM standards.
- Develop reports using tools like JREVIEW
- Develop custom reports in SAS or SQL
- knowledge with C-Sharp and custom function programming
- The ability to design feeder studies is a plus
- Early Phase Oncology or Immuno Oncology is a plus
- Experience with Oncology Studies is a BIG plus
Introduction to the Organization
The Parker Institute for Cancer Immunotherapy (“PICI” or the “Parker Institute”) is a not-for-profit organization whose mission is to accelerate the development of immunological cures for cancer through innovative science, advanced technologies and new modes of research collaboration. The Institute is based in San Francisco, California and officially launched in April 2016.
To achieve its mission, PICI has established significant new cancer immunology research centers at six of the top cancer research and treatment institutions in the country (Memorial Sloan Kettering Cancer Center, Stanford Medicine, the University of California, Los Angeles, the University of California, San Francisco, the University of Pennsylvania and The University of Texas MD Anderson Cancer Center), and will organize and support a portfolio of advanced, collaborative research efforts across this consortium.