Technical Data Standards Architect

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

Benefits offered by this job

Health benefits

Bonus potential

Job summary

IQVIA seeks an experienced SAS programmer to lead ADaM data programming efforts and develop process methodologies for client projects in the pharmaceutical arena. You will plan and coordinate integrated programming solutions, provide technical leadership to the department, and support internal consulting on complex specifications for submissions.

Strong knowledge of ADaM datasets, CDISC standards, experience with data validation tools, and the ability to manage multiple tasks under tight

Qualifications

• BA/BS degree or equivalent experience in a relevant field.
• 4–8 years of SAS programming in the pharmaceutical industry.
• Strong SAS skills with emphasis on ADaM datasets and ADaM standards management.
• Knowledge of regulatory guidelines including electronic submission standards.
• Strong organizational, time management, communication, and leadership skills.
• Ability to work under timeline pressure and handle multiple tasks simultaneously.

Responsibilities

• Provide technical leadership to develop process methodologies for department.
• Plan and coordinate development of integrated programming solutions for statistical needs.
• Provide internal consulting including specifications and user needs analysis for complex projects.
• Support both development and ongoing maintenance of ADaM metadata programming.

Skills

SAS programming

ADaM datasets

Regulatory guidelines knowledge

Project coordination

Communication

Education

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

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.