Clinical Data Standards Specialist

Gaithersburg, MD 20697

Posted: 05/09/2019 Category: Pharmaceutical Job Number: 281661-4_1
Smith Hanley Associates
Clinical Data Standards Specialist
Gaithersburg, MD
Nihar Parikh - [email protected]

Our client is a global biopharma organization and has an opening in clinical data management and statistical programming. In this leadership role you will oversee clinical data standards, manage processes, and define strategy on drug development using industry leading data systems.

Provide expertise on CDISC standards, metadata management and the end to end alignment of clinical data standards and their application in drug projects.
Drive clinical design to generate the date required for decision making.
Develop clinical data standards including SDTM, ADaM, and output standards.
Implement the data standards strategy, provide standards consulting advice to external teams and applications for clinical studies.
Play a key role in delivering the vision for programming.

Degree in Computer Science, Mathematics, Statistics or Life Sciences field.
Strong CDISC experience and a background in data management and statistical programming.
Proficient in clinical data standards such as CDASH/SDTM/ADaM CDISC.
Knowledge of the clinical drug development process, clinical databases, and data reporting.
Experience with regulatory requirements and SAS programming.
Experience with Knowledge Graph and MediData Rave systems a plus.
Strong communication skills and project management experience.

Smith Hanley Associates is a niche recruiting agency with expertise in Biostatistics.


Nihar Parikh
Executive Recruiter

Nihar manages recruiting in biostatistics and other clinical areas. He likes recruiting because it allows him to impact a company’s greatest asset, their employees.  

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