Technical Data Standards Architect

IQVIA•Durham, NC

3d•$88,300 - $220,900

About The Position

Provide experienced technical expertise to develop process methodology for department to meet internal and external clients’ needs. Plan and coordinate the development of integrated programming solutions serving the full spectrum of statistical programming needs. Provide technical expertise and leadership to the department. Provide internal consulting services, including specifications and user needs analysis for complex project or client requirements.

Requirements

BA/BS degree in mathematics, statistics, computer science or health related field. Or equivalent experience
4 – 8 years of SAS programming working experience in the pharmaceutical industry.
Good SAS programming skills and attention to details, especially in ADaM datasets and managing ADaM standards
Demonstrated knowledge of regulatory guidelines, including electronic submission standards.
Strong organizational, time management, communication, and project coordination and leadership skills.
Must be able to work well under timeline pressure.
Must be able to work on multiple tasks while coordinating others at the same time.
Strong understanding of CDISC ADaM datasets and experience in managing ADaM standards
Hands on experience with P21 for data validation
Basic knowledge and understanding of eSubmission docs (ADRG, DEFINE)

Nice To Haves

Knowledge on Tables listings and figures is an added advantage.

Responsibilities

Actively support both the development and ongoing maintenance of standard ADaM metadata programming.
Provide technical expertise and leadership to the department.
Provide internal consulting services, including specifications and user needs analysis for complex project or client requirements.
Plan and coordinate the development of integrated programming solutions serving the full spectrum of statistical programming needs.