Technical Data Standards Architect

IQVIA; Durham (NC); On-site; USD 88,000 - 221,000; Full time

Job summary

IQVIA is seeking a technically skilled professional to develop process methodologies for the statistics programming department and coordinate integrated programming solutions for clients.

The role requires hands-on SAS programming experience in the pharmaceutical industry, strong ADaM knowledge, and ability to lead projects under tight timelines.

Qualifications

• BA/BS in math, stats, CS or health-related field, or equivalent experience.
• 4–8 years SAS programming in pharmaceutical industry.
• Strong attention to detail in ADaM datasets and standards.
• Understanding regulatory guidelines and electronic submission standards.
• Ability to lead and coordinate projects under timelines.

Responsibilities

• Develop process methodology for the department to meet internal and external client needs.
• Plan and coordinate development of integrated programming solutions for statistical programming needs.
• Provide technical leadership and internal consulting on specifications and user needs for complex projects.
• Collaborate with project teams to ensure timely delivery of deliverables.
• Support ADaM metadata development and data validation efforts.

Skills

ADaM metadata development

CDISC ADaM datasets management

P21 validation

eSubmission docs (ADRG/DEFINE)

Tables & figures knowledge

Education

BA/BS in mathematics, statistics, CS or health-related field

4–8 years SAS programming in pharma

Tools

SAS

Job description

Job Overview

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.

Job Overview

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.

Technical Skillset

• Actively support both the development and ongoing maintenance of standard ADaM metadata programming.
• 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)
• Knowledge on Tables listings and figures is an added advantage.
  

Qualifications (Minimal acceptable level of education, work experience, and competency)

• 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.
  

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
The potential base pay range for this role, when annualized, is $88,300.00 - $220,900.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.