Data Standard Analyst - Biostatistics Team

				Overview:

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

Responsibilities:

* Implement edit check specifications via SAS programming to assist with reconciliation of data discrepancies;
* Create annotated CRFs and mapping specifications per CDISC SDTM standards;
* Create SDTM data via SAS programming by implementing data standards for collected study level source data;
* Perform validation of CDISC SDTM data in accordance with SOPs and guidance documents;
* Ensure SDTM data conforms to the data standards expected by regulatory agencies;
* Assist with creation of the define package for submission to regulatory agencies;                              

Qualifications:

* Bachelor's Degree in Math, Statistics, Life Sciences, or equivalent
* SAS programming knowledge preferred

TRAVEL: None
			

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