[Hiring] Senior Lead Clinical Data Science Programmer @ICON plc

Role Description

As a Senior Lead Clinical Data Science Programmer at ICON, you will be instrumental in leading the development and implementation of advanced data science solutions for clinical trials.

You will manage day-to-day clinical data science activities, supporting your team to deliver quality outcomes.

• Lead the development of Data Transfer Specifications (DTS) documents to align external data providers and research partners on the required structure for new data. This includes:
  • Authoring the DTS, responding to external data providers and internal stakeholder queries to ensure data will be delivered in the correct format and structure.
  • Track DTS status with external data providers across different data types and programs and ensure data completion dates are met for study timelines and deliverables.
  • Ensuring data structure based on the type(s) of data being used is consistent and compliant with appropriate data templates.
  • Ensuring data structure is consistent across each data provider and comply with appropriate data templates.
  • Support data reconciliation and data structure inquiry resolution.
  • Liaise cross functionally to facilitate the creation of new test codes.
  • Participate in the Clinical Study Team as an extended team member.
  • Oversee and train in the use of the DTS and other supplemental documents.
  • Contribute to improvement initiatives as it relates to external data process.
  • Ensure study teams adhere to CDISC standards as it relates to external data.
  • Comply with all pertinent regulatory agency requirements (Understand clinical protocols and requirement for Biomarkers/Imaging/eCOA data, blinding and analysis expectations).
  • Process change requests to update existing DTS.
  • Improve templates for existing DTS to ensure data harmonization and downstream analytics.
  • Provide external data management oversight to vendors, providing a pathway for functional discussions, partnership level processes & standards, portfolio status, communication, and escalation.
  • Review and contribute to eCRF and EDC builds as it relates to external data requirements.

Qualifications

• Solid clinical data science experience, with the ability to manage competing priorities and develop your team.
• Expertise in biomarker data types and/or Imaging data for oncology and non-oncology studies is preferred.
• Experience working with multiple data types/formats.
• Experience in managing clinical, biomarker data, eCOA and imaging data.
• Demonstrates broad knowledge of all applicable regulations including 21 CFR Part 11, ICH-GCP Guidelines and CDISC standards for data collections.
• Demonstrates advanced knowledge of Data Management processes and industry best practices.
• Advanced knowledge and experience with extracting data into SAS, CSV, and XML formats is required.

Requirements

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

Benefits

• 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.