Career

Clinical Data Standards Manager (SDTM)

Information Technology

United States - NY, New York

Requisition ID

999008486

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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.

Our Team: 

Medidata is looking for individuals who will help us tackle some of the most complex questions facing the industry today using our proprietary platform and advanced analytics. At Medidata, we never work alone. This role will partner heavily with all of the key stakeholder functions including product, delivery, data science, engineering, partnerships, and biostatistics. Successful Medidata AI candidates will be skilled in analytical/quantitative thinking, structured communication, and excited about building the next horizon of Medidata’s mission to power smarter treatments and healthier people.

Who We're Looking For: 

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.

Requirements (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

The salary range posted below refers only to positions that will be physically based in New York City. As with all roles, Medidata sets ranges based on a number of factors including function, level, candidate expertise and experience, and geographic location. Pay ranges for candidates in locations other than New York City, may differ based on the local market data in that region. The base salary pay range for this position is $114,000 to $153,000.

Base pay is one part of the Total Rewards that Medidata provides to compensate and recognize employees for their work. Most sales positions are eligible for a commission under the terms of applicable plan documents, while many of Medidata’s non-sales positions are eligible for annual bonuses. Additionally, Medidata provides best-in-class Benefits. We believe that benefits should connect you to the support you need when it matters most and should help you care for those who matter most. For that reason, we provide an array of options to help support you physically, financially and emotionally through the big milestones and in your everyday life.

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Equal Employment Opportunity

In order to provide equal employment and advancement opportunities to all individuals, employment decisions at Medidata are based on merit, qualifications and abilities. Medidata 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, disability, veteran status, military service, application for military service, genetic information, receipt of free medical care, or any other characteristic protected under applicable law. Medidata 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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