The Clinical Data Standards Manager is a key role on the Data Science team, composed of PhD/Masters statisticians, data scientists, analytical product leads, former FDA biostatisticians and computational genomicists. We leverage industry leading data assets and analytical models to transform the clinical development industry, driving scientific and operational success for our clients and partners. The Clinical Data Standards Manager will help drive the development and commercialization of new data-driven and cloud based analytics software products.
● Use deep knowledge of clinical data management standards and systems to discover and map data elements from raw clinical trials data files to CDISC and internal standard data models and controlled terminologies to support construction of precision clinical analytics data assets and predictive models.
● Serves as SDTM SME, supporting all SDTM programming and regulatory submission-related activities with vendors and internal team.
● Lead and/or conduct QC of work described all the above that is done by others.
● Coordinates with vendors for SDTM development, develops/manages best practices for them and oversees their deliverables
● Work with statisticians, data scientists, programmers, and project managers to understand and resolve clinical data standardization needs and meet customer project delivery deadlines.
● Understand and convert analytical data requirements to data collection domain/variables following CDISC and internal data models and controlled terminologies.
● Participate in reviewing hundreds of trials from multiple sponsors and make recommendations for data standardization rules.
● Use internal tools to review outputs of data standardization algorithms and automated statistical reports on multiple pooled trials, validating mappings and making recommendations to improve data quality and model performance.
● Perform ad hoc quality analyses on clinical trials data.
● Participate in the development of cross functional SOPs, Working Procedures and Guidance documents related to SDTM.
● Serve as knowledge and training resource to internal teams on SDTM and clinical data capture practices.
Your Education & Experience:
● BA/BS, Masters preferred, in a life science discipline.
● Minimum 10 years progressive experience at multiple companies in the pharmaceutical/CRO setting including depth in all the following:
● SDTM development for submissions
● Clinical data manager or data standards manager
● Participation in eCRF and EDC design
● Clinical trials data collection and data QC processes
● Requires extensive knowledge of Clinical Data Management, SDTM, and the creation of data mapping specifications.
● Knowledge of data structures within clinical data management systems
● Basic working knowledge of SAS or SQL for data exploration
● Strong documentation, communication, and interpersonal skills
● Prefer experience with oncology trials
● Medical background is a plus
● Prefer experience with pooled clinical trials data and/or Integrated analysis (ISS, ISE etc)
● Prefer knowledge/experience in ADaM standards and development
● Prefer experience with Medidata Rave
● Prefer experience working with vendors