# CDISC Standards Specialist

**Company**: IQVIA
**Experience**: senior
**Job type**: full-time
**Category**: Consulting
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Reading-Berkshire-United-Kingdom/Data-Standards-Engineer_R1573235?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_9539acf2-03c

## Description

This position is responsible for the development of the end-to-end design of client standards and study specifications that align to the CDISC standards and regulatory agency guidance’s.

You will support clients and IQVIA as an authority in the use of CDISC Standards through communication, collaboration, training, and mentorship. You will partner with project statisticians and programming teams to develop global tools to support project programming needs in the use of CDISC Standards. You will lead the implementation of productivity tools for IQVIA and clients which improve compliance, efficiencies, and timeliness of deliverables to clients.

Key responsibilities include:

- Providing training and mentorship for the use of technology and systems, such as metadata repositories, to support IQVIA and client’s in their use

- Ensuring that work delivered to clients meets minimum submission requirements as defined by FDA Guidance Documents and other regulatory guidance

- Guiding clients in their use of CDISC standards through governance teams

- Monitoring regulatory authority and standards organization sites for updates and informing IQVIA leadership of updates

- Working on other IQVIA initiatives as a CDISC representative

- Interacting with various CDISC sanctioned teams in the development of standards

- Representing IQVIA in the industry as a leader in the use of Standards and Automation

- Supporting leadership in the development of processes and tools which enable CDISC compliance

Minimum requirements:

- Bachelor's Degree in computer science, statistics, or a related area

- Experience with CDISC Standards, specifically SDTM and ADaM

- Experience on industry team involved in standards such as CDISC, HL7, or Transcelerate

- Strong communication skills

- 10 years SAS programming experience or other related programming language experience preferred

- Knowledge of macro or subroutine development is expected

- Knowledge and experience in two or more programming languages such as SAS, R, Python, Julia, C#, Java, or other language

- Relevant statistical programming experience with pharmaceutical clinical trial data preferred

- Experience in mentoring and developing others in the use of CDISC standards

- Experience in submissions to regulatory authority preferred

## Skills

### Required
- CDISC Standards
- SDTM
- ADaM
- SAS programming
- communication skills

### Nice to have
- R
- Python
- Julia
- C#
- Java

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