Senior Clinical Data Science Programmer

Overview

Job Title: Senior Clinical Data Science Programmer

Location: Bangalore/Chennai [Hybrid Model]

As a Senior Clinical Data Science Programmer at ICON, you will be responsible for implementing and maintaining efficient standard content in data collection and delivery tools. You will support metadata standards that facilitate the seamless data flow from collection to delivery in alignment with industry standards and regulatory requirements. This role will work in close collaboration with clinical data collection and analysis teams to ensure optimal adoption and reuse of standards across trials and therapeutic areas.

This position has two main focus areas:

• Data Collection – Focusing on CRFs, DTAs, and Rave eDC standards

• Data Delivery – Focusing on SDTM, controlled terminology, and metadata mapping

Responsibilities

Standards Development & Configuration:

• Design, implement, and manage clinical data standards across collection and delivery tools to enhance trial efficiency and data consistency.

• Tailor standards to meet the scientific and operational needs of specific disease or therapeutic areas.

• Ensure robust traceability from master standards through to study-specific implementations, maintaining detailed metadata lineage.

Data Collection Focus (if applicable):

• Implement standard content in Medidata Rave eDC, including:

  • CRF mockups

  • Standard questionnaires and COAs

  • Validation rule specifications

  • Standard integrations (e.g., IWRS)

Data Delivery Focus (if applicable):

• Annotate CRFs with SDTM-compliant metadata to support regulatory submissions and operational excellence.

• Support content such as:

  • SDTM and define.xml creation

  • Annotated CRFs

  • Data Transfer Agreement standards

  • Metadata mapping (CRF/DTA to DRM, DRM to SDTM)

Collaboration & Support:

• Act as a standards expert and advisor to clinical data management and clinical programming teams, as well as CRO partners.

• Provide guidance on effective adoption and implementation of standards across global studies.

Key Interfaces:

• Primary: Standards leads (data collection and delivery), Data Managers, Technical Data Architects

• Secondary: Clinical teams (statisticians, physicians), Clinical Analysis Standards, CDISC working groups

Qualifications

For Data Collection Focus:

• Strong hands-on experience with Rave eDC (Medidata Solutions)

• SAS programming knowledge preferred

For Data Delivery Focus:

• Experience with SAS programming for clinical data standards

• Exposure to Rave eDC is advantageous

Common Requirements:

• Solid understanding of CDISC standards (SDTM, CDASH, Controlled Terminology, define.xml)

• Experience with SAS LSAF and Pinnacle 21 is a plus

• Bachelor’s degree in Life Sciences, Computer Science, or equivalent professional experience

• Minimum of 2 years in clinical data management, standards, or related functions

• Strong organizational skills and the ability to manage multiple priorities

• Excellent written and verbal communication skills in English

What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. https://careers.iconplc.com/reasonable-accommodationsInterested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.