Technical Data Standards Architect

IQVIA; North Carolina; On-site; USD 88,000 - 221,000; Full time

Job summary

IQVIA is seeking a senior SAS programmer to develop methodology for the department and coordinate integrated programming solutions for ADaM datasets. You will provide technical leadership, analyze client requirements, and offer internal consulting on complex projects.

The role emphasizes adherence to regulatory guidelines, strong organizational skills, and the ability to manage multiple tasks under tight timelines in a pharmaceutical setting.

Qualifications

• BA/BS degree in mathematics, statistics, computer science or health related field, or equivalent experience.
• 4–8 years SAS programming experience in the pharmaceutical industry.
• Strong SAS skills with attention to ADaM datasets and standards.
• Regulatory guidelines knowledge, including electronic submission standards.
• Strong organizational, time-management, communication, and leadership skills.

Responsibilities

• Provide experienced technical expertise to develop process methodology for the department.
• Plan and coordinate development of integrated programming solutions for SAS needs.
• Provide internal consulting, including specifications and user needs analysis for complex projects.
• Demonstrate technical leadership within the department and coordinate multi-task efforts.

Skills

SAS programming

ADaM metadata

Leadership

Communication

Time management

Project coordination

Regulatory knowledge

Education

BA/BS in math or statistics

Tools

SAS

ADaM standards

P21 validation

eSubmission docs

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.

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.