CDISC Data Specialist

Frederick, Maryland
Oct 15, 2019
Nov 07, 2019
Full Time
The Emmes Company, LLC is searching for a CDISC Data Specialist located in our Rockville, Maryland or Frederick, Maryland office. Emmes provides flexibility for office location preference, dependent upon position.

The Emmes Company, LLC is a private Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.

Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation. Emmes is seeking a CDISC Data Specialist with expertise in CDISC Study Data Tabulation Model standards to conduct SDTM mapping, review, and verification of conformance with current CDISC guidelines.


  • Review protocols for CDISC conformance
  • Develop and review Case Report Forms and eCRFs with CDISC CDASH and SDTM conformant elements
  • Utilize proprietary Emmes software and mapping tools to annotate eCRFs and create data elements for SDTM output
  • Review and verify SDTM data elements, SDTM annotations, and SDTM datasets and their conformance with the SDTM Implementation Guide, project standards, and the study protocol
  • Create and review submission ready SDTM datasets, define.xml, and supporting documentation, as appropriate
  • Provide CDISC training and serve as a subject matter support to project staff
  • Maintain and coordinate CDISC standards efforts, ensure maximum reuse of applied standards, involvement in ongoing process improvement efforts and working with teams to provide technical and process guidance
  • Stay current with the evolution of all CDISC standards and be involved in creation and maintenance of process documentation


  • Bachelor's degree or Master's degree with 2 years related experience, and demonstrated working knowledge of scientific principles appropriate to the position
  • Excellent oral and written communication skills
  • Prior experience with Good Clinical Data Management Practices
  • Prior experience with CDISC SDTM standards and application of standards to clinical trial data
  • Documented training in CDISC SDTM, strongly preferred
  • Prior experience with SQL and other database programming is preferred
  • Strong interpersonal skills and ability to work with staff at all levels with sensitivity and tact
  • Demonstrated ability to foster concepts of teamwork, research integrity, ethical conduct, and personal responsibility
  • Ability to self-direct and work independently and in a complex team environment
  • Knowledge of clinical research including the critical elements for the development and execution of clinical trials or research studies
  • Strong skills in prioritization, organization, problem solving, decision-making, time management, mentoring, and planning

Emmes has an outstanding benefits package including: generous tuition reimbursement, professional development and training programs.


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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

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