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.
Medidata AI is one of the largest AI companies exclusively dedicated to life sciences. It's built on Medidata's platform that includes the industry's largest structured, standardized and growing clinical trial data repository drawing from 20,000+ trials and 6.5M patients. Medidata AI is now curating unique, fit-for-regulatory purpose datasets with advanced analytics. We are composed of data scientists, biostatisticians, data engineers, data stewards, and analytics product experts.
Who We’re Looking For:
- Reporting to the Director, Clinical Data Standardization, 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.
- Standardize historical clinical trials data using CDISC SDTM standards, internal conventions and controlled terminologies to support construction of clinical analytics solutions and predictive models.
- SDTM subject matter expert, supporting SDTM programming and regulatory submission-related activities with internal and external teams.
- Lead and conduct QC of SDTM mapping and conversion
- Maintain SOPs, work instructions and guidance documents related to clinical data standards and SDTM.
- Work with statisticians, data scientists, programmers, and project managers to meet customer engagement delivery timelines.
- Contribute to the development of novel technology, models and algorithms to improve the standardization of historical clinical trial data
Requirements (Education & Experience):
- Bachelor's degree in life science or a quantitative discipline required.
- Minimum 8 years progressive experience (at least 7 years in SDTM) in the pharmaceutical/CRO setting
- 5+ years experience developing full SDTM packages for regulatory submission
- Experience in EDC database design (e.g., Rave) including knowledge of eCRF form and field data structures
- Experience with the latest SDTM versions and creating data mapping specifications.
- Knowledge in ADaM standards
- Working knowledge of SAS, SQL or equivalent tool for data exploration
- Experience with pooled clinical trials data or Integrated analysis (ISS, ISE)
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 $114,750 to $150,000.
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.
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.
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.