Principal Clinical Data Standards Consultant New

NetVerks Inc.; Bengaluru; On-site; INR 2,600,000 - 4,200,000; Full time

Job summary

ICON is a global healthcare intelligence and clinical research organisation dedicated to advancing medicines. ICON seeks a Principal Clinical Data Standards Consultant to design, analyze, and standardize data for complex clinical trials, integrating CDISC standards and regulatory requirements.

The role focuses on coordinating consulting services, developing data standards tools (CDASH, SDTM, Define-XML, ADaM) and training materials, while leading a team and collaborating with cross-functional

Qualifications

• Bachelor's degree in life sciences, CS or related discipline.
• SDTM expert with SAS, R experience.
• 8+ years in clinical data standards roles in pharma/biotech.
• Strong leadership and cross-functional collaboration.
• Willingness to travel ~15%.

Responsibilities

• Coordinate consulting and advisory services delivery.
• Develop tools for CDISC standards (CDASH, SDTM, Define-XML, ADaM).
• Collaborate with cross-functional teams to define data collection strategies and standards.
• Develop and maintain training and reference materials for standards topics.
• Keep abreast of industry trends and regulatory updates and integrate into ICON practices.

Skills

SDTM expert

SAS

R

CDISC standards

Data management

Regulatory knowledge

Leadership

Education

Bachelor's degree in life sciences, CS or related

Job description

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

Prinicipal Clinical Data Standards Consultant

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 values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

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.

What You Will Do

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

Key responsibilities

• As a Senior Clinical Data Standards Consultant at ICON Plc, you will be responsible for:
• 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.
• Should have a 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.
• Should demonstrate 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%)

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

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

• 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

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.