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Reporting to the Director, Data Science, you will lead the industrialized standardization of historical clinical trial data using industry standards (e.g., SDTM, ADaM) and related processes. Working collaboratively with all the team leads you will provide high-quality, regulatory-compliant standardized data to improve clinical trials. The Clinical Data Standards Manager will provide technical expertise and documentation for SDTM data standardization activities and will help implement proprietary algorithmic data standardization models.
Use the 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 clinical analytics data assets and predictive models.
Be the SDTM subject matter expert, supporting all SDTM programming and regulatory submission-related activities with vendors and internal team.
Lead and conduct QC of the work described all the above that is done by others.
Coordinate with the vendors for SDTM development, develops/manages best practices for them and oversee 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.
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.
Help to develop the cross functional SOPs, Working Procedures and Guidance documents related to SDTM.
Be the knowledge and training resource to our teams on SDTM and clinical data capture practices.
Your Education & Experience:
Bachelor's degree in life science or a quantitative discipline required.
Minimum 10 years progressive experience (at least 7 years in SDTM) at multiple companies in the pharmaceutical/CRO setting including depth in most of the following:
SDTM development for submissions with full package
Clinical data manager or data standards manager including managing/using CT from CDISC and extending it for sponsor specific.
Participation in EDC databases design and knowledge of eCRF forms and fields data structures
Clinical trials data collection and data QC processes
Requires knowledge of SDTM in latest versions and the creation of data mapping specifications.
Working knowledge of SAS or SQL or equivalent tool for data exploration
Prefer experience with oncology trials
Prefer experience with pooled clinical trials data or Integrated analysis (ISS, ISE)
Prefer knowledge in ADaM standards
Prefer experience with Medidata Rave
Prefer experience working with vendors
Medidata requires all U.S. employees to be fully vaccinated against COVID-19 and to provide documentation of full vaccination, unless qualified for an accommodation as determined by Medidata, consistent with applicable law. Although accommodation requests will be considered (and granted where appropriate/possible), it may be determined that a candidate is unable to adequately perform the essential functions of the position without imposing an undue hardship on Medidata due to customer requirements, staffing needs, or other business reasons
Medidata Solutions, Inc. is an Equal Opportunity Employer. Medidata Solutions provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability status, protected veteran status, or any other characteristic protected by the law. Medidata Solutions complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities.
MEDIDATA generates the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes.