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Clinical Data Standards Analyst At Medidata Solutions

Location: New York, New York

Job Description

Medidata is leading the digital transformation of life sciences with the world's most-used platform for clinical development, commercial and real-world data. Powered by artificial intelligence and delivered by #1 ranked industry experts, the Intelligent Platform for Life Sciences helps pharmaceutical, biotech, medical device companies and academic researchers accelerate value, minimize risk and optimize outcomes. Medidata serves more than 1,000 customers and partners worldwide and empowers more than 100,000 certified users every day to create hope for millions of patients. Discover the future of life sciences: www.mdsol.com

We know that diverse teams win and are fully committed to selecting leaders and employees that represent the markets in which we operate. We are still led by our Co-founders, Tarek Sherif and Glen de Vries, and have global operations in US, Europe and Asia with over 2000 employees.

Your Competencies:

  • Use deep knowledge of clinical data standards and systems to map data elements from raw clinical trial data files to SDTM & internal standard data models and controlled terminologies
  • Conduct QC of work described above that is done by others.
  • Communicate with biostatisticians to understand data requirements.
  • Assist converting the analytical data requirements to SDTM domains/variables and controlled terminologies.
  • Review standardizations across thousands of trials from multiple sponsors and make recommendations.
  • Work with statisticians, data scientists, programmers, and project managers to resolve clinical data definitions and meet customer project delivery deadlines.
  • Perform ad hoc quality analyses on clinical trials data.
  • Serve as knowledge and training resource to internal teams on eCRF designs, SDTM, and clinical data capture practices.

Your Education & Experience:

  • BA/BS, Masters preferred, in a life science discipline.
  • Minimum 5 years progressive experience at multiple companies in the pharmaceutical/CRO setting including depth in all the following:
    • SDTM mapping specifications
    • Clinical data management or data standards management
    • Participation in eCRF and EDC design
    • Clinical trials data collection and data QC processes
  • Good documentation, communication and interpersonal skills
  • Knowledge of data structures within clinical data management systems.
  • Basic working knowledge of SAS or SQL for data exploration.
  • Prefer experience with oncology trials.
  • Prefer experience/knowledge in ADaM

Medidata is making a real difference in the lives of patients everywhere by accelerating critical drug and medical device development, enabling life-saving drugs and medical devices to get to market faster. Our products sit at the convergence of the Technology and Life Sciences industries, one of most exciting areas for global innovation. Nine of the top 10 best-selling drugs in 2017 were developed on the Medidata platform.

Medidata’s solutions have powered over 14,000 clinical trials giving us the largest collection of clinical trial data in the world. With this asset, we pioneer innovative, advanced applications and intelligent data analytics, bringing an unmatched level of quality and efficiency to clinical trials enabling treatments to reach waiting patients sooner.

EEO Statement

US:
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.

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