Be the next big change > Dassault Systèmes

Be the Next Game Changer

Clinical Data Standards Manager (SDTM)

United States, NY, New York
Regular
8/4/2022
999008486

Medidata: Power Smarter Treatments and Healthier People


Medidata is leading the digital transformation of life sciences, creating hope for millions of patients. Medidata helps generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes. More than one million registered users across 1,900+ customers and partners access the world's most trusted platform for clinical development, commercial, and real-world data. Medidata, a Dassault Systèmes company, is headquartered in New York City and has offices around the world to meet the needs of its customers. Discover more at www.medidata.com and follow us @medidata.

 

Your Mission:

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.

 

Your Competencies:

  • 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.  

Not available

Equal opportunity

In order to provide equal employment and advancement opportunities to all individuals, employment decisions at 3DS are based on merit, qualifications and abilities. 3DS is committed to a policy of non-discrimination and equal opportunity for all employees and qualified applicants without regard to race, color, religion, gender, sex (including pregnancy, childbirth or medical or common conditions related to pregnancy or childbirth), sexual orientation, gender identity, gender expression, marital status, familial status, national origin, ancestry, age (40 and above), disability, veteran status, military service, application for military service, genetic information, receipt of free medical care, or any other characteristic protected under applicable law. 3DS will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Covid statement

Our Company requires all U.S. employees to be fully vaccinated against COVID-19 and to provide documentation of full vaccination, unless qualified for a medical, religious or state-required accommodation or otherwise exempt 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 due to customer requirements, staffing needs, or other business reasons. Definition of full-vaccination: Employees are considered to be fully vaccinated two weeks after their second dose in a 2-dose series or two weeks after a single-dose vaccine.
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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.