# Principal Clinical Data Standards Consultant

**Company**: ICON
**Location**: Bangalore, India
**Experience**: senior
**Job type**: full-time
**Category**: Consulting
**Industry**: Healthcare

**Apply**: https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/India-Bangalore/Principal-Clinical-Data-Standards-Consultant_JR156966?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
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## Description

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a Principal Clinical Data Standards Consultant at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.

**Responsibilities**

Your focus will be on coordinating consulting and advisory services delivery, resolving issues, and developing team capability. Key responsibilities include:

- Developing tools to aid in the implementation and compliance of CDISC, Sponsor, and ICON standards.

- Collaborating with cross-functional teams to define data collection strategies and standards for clinical trials.

- Developing and maintaining training and reference materials related to standards topics including CDASH, SDTM, Terminology, ADaM, define-XML and regulatory submission requirements.

- Managing the development and maintenance of data management processes and tools.

- Keeping abreast of industry trends and regulatory updates related to data standards and ensuring their integration into ICON's practices.

**Your Profile**

You will have solid consulting and advisory services experience, with the ability to manage competing priorities and develop your team. Required qualifications and experience:

- Bachelor's degree in life sciences, computer science, or a related discipline

- SDTM expert with a background that includes programming in SAS, R and other languages.

- Minimum of 8 years experience in the industry in roles that demonstrate the knowledge and skill in the above.

- Statistical programming role focused on SDTM tasks.

- Leadership skills

- Extensive experience in clinical data management and standards within the pharmaceutical or biotechnology industry.

- Advanced Proficiency in CDISC (Clinical Data Interchange Standards Consortium) standards and relevant regulations (e.g., FDA, EMA).

- Excellent analytical and problem-solving skills with a keen attention to detail.

- Excellent communication and collaboration abilities to work effectively in cross-functional teams.

- Willingness to travel as required (approximately 15%)

**Rewards & Benefits**

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

- Competitive base salary and performance related incentives

- Health and wellbeing programmes including medical, dental, and vision coverage where applicable

- Retirement and pension plans

- Life assurance and disability coverage

- Employee assistance programmes and wellbeing resources

- Learning and development opportunities through structured training and career pathways

## Skills

### Required
- CDISC
- CDASH
- SDTM
- ADaM
- define-XML
- SAS
- R
- clinical data management
- data standards

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