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Senior Analyst, Data Standards

5 months ago

Little Ferry, United States Talentify.io Full time

Employer Industry: Pharmaceutical

Why Consider This Job Opportunity

Competitive pay up to $130,000 Opportunity for career advancement and growth within the organization Remote work opportunity within the US Comprehensive benefits package including medical, dental, and vision coverage Chance to contribute to innovative medicines and solutions Collaborative and supportive work environment

What To Expect (Job Responsibilities)

Define SDTM mapping and data collection standards within assigned therapeutic areas Educate the organization on the proper use of standards in pipeline activities Create and review SDTM Mapping Specifications and Trial Design Domains Provide feedback on CRF design and SDTM datasets to ensure compliance with CDISC standards Oversee the creation of SDTM define.xml, annotated CRF, and Clinical Study Data Reviewer's Guides

What Is Required (Qualifications)

MS with 6 years of relevant clinical research experience or BS with 8 years of relevant clinical research experience Expert knowledge of CDASH, SDTM, ADaM, define.xml, and controlled terminology Experience in mapping and converting legacy data into SDTM domains for eCTD submissions Knowledge of international regulations related to clinical data standards Experience with metadata repository technology or data standards governance

How To Stand Out (Preferred Qualifications)

Familiarity with clinical data standards including BRIDG, ODM, and SHARE

#Pharmaceutical #ClinicalResearch #DataStandards #RemoteWork #Innovation

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