Data Integration and Standardization Specialists
Location:
Wayne, PA
Octagon's novel culture focuses on fostering innovation, encouraging personal growth, and promoting entrepreneurship. Leveraging the experience gained from the successful submission of over 200 NDAs and 500 electronic submissions to the FDA, Octagon continues to lead the industry in data conversion and the implementation of new standards. Our SDTM related experience includes a track record of over 250 studies (3,200 datasets).
To be a successful Specialist prior knowledge may include:
- Experience in clinical data management, specifically protocol assessment, case report form (“CRF”) design, understanding of clinical data management systems (“CDMS”), study start up (e.g., database administration, edit check creation, data validation) and database lock
- Experience in producing derived/analysis datasets from raw/CDMS extracts would also be advantageous for this position; as an alternative career path, the ideal candidate should have experience: reviewing source data and annotated CRF; developing, reviewing, and/or utilizing database mapping specifications used to produce analysis datasets from source datasets; and implementing programs to accomplish the mapping outlined by these specifications. It is a great opportunity to learn new tools and techniques to accomplish a familiar, business critical task
- Experience in taking a lead role in studies
Technical responsibilities may include the following tasks:
- Review and analyze source (raw) data
- Create mapping specifications from source (raw) data to target (CDISC SDTM and/or sponsor defined standards)
- Perform quality control of mapping specifications and CDISC SDTM outputs
- Create annotated CDISC SDTM CRFs and data definition files
Candidates should have a combination of the following:
- Four-year college degree (Life Science, Mathematics, Applied Statistics or Computer Science)
- 3+ years of industry experience (Pharmaceutical, Biotechnology, or CRO)
- Experience in interacting with a project team
- Possess the ability to effectively manage time, prepare for meetings, prioritize project work
Octagon is an Equal Opportunity Employer with an outstanding corporate culture. Please visit us at www.octagonresearch.com to learn more about how we are revolutionizing the drug development lifecycle.
