Data Standards Specialist

Location: Amherst, NY

Frontier Science in Amherst, NY is the data management center for multiple clinical trials funded by the National Institutes of Health (NIH).

The Data Standards Specialist assists with the development of data collection instruments that comply with Clinical Data Acquisition Standards Harmonization (CDASH) standards and works on related projects in support of Clinical Data Interchange Standards Consortium (CDISC) implementation standards.

Data Standards Specialists coordinate the annotating, modeling and mapping of the Study Data Tabulation Model (SDTM) for assigned studies and maintain these mappings throughout the life of the study, including QA/QC, traceability and validation of the data flow to SDTM. They define additional processing requirements for the final SDTM, working closely with computer programmers and statisticians as they develop Analysis Data Model (ADaM) datasets.

We are looking to add a Specialist to our team. The selected candidate will be asked to complete CDASH and SDTM training if not previously trained. Candidates will be working in a dynamic, fast-paced environment and need to be comfortable learning and working with a variety of software programs. Experience with the Medidata Rave EDC is preferred, but not required.

A Bachelor’s degree in a Science, Math, Biostatistics, or a closely related field as well as excellent communication skills, both written and verbal, are required. This person must also be a team player, be able to multi-task, and have excellent attention to detail.

Experience in data management on clinical trials is highly preferred as is SDTM experience, preferable in clinical research or pharma programming. Proficiency in SQL and MS Excel, as well as knowledge of relational database structures and complex data systems is a plus.

Entry-level salary is $47,000.

This position is located in our Amherst, NY office and cannot be done remotely.

Submit resumes to jobs@fstrf.org and include SDTM201912 in the subject line.

All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, disability, or veteran status.