Senior Lead Clinical Data Science Programmer
On-site · Bengaluru, Karnataka, India or Chennai, Tamil Nadu, India
Job Summary
Lead the development and implementation of advanced data science solutions for clinical trials. Manage day-to-day clinical data science activities, supporting your team to deliver quality outcomes. Key responsibilities include: Lead the development of Data Transfer Specifications (DTS) documents to align external data providers and research partners on the required structure for new data. Author the DTS, respond to queries to ensure data will be delivered in the correct format and structure. Track DTS status with external data providers across data types and programs ensuring data completion dates are met. Ensure data structures are compliant with data templates and CDISC standards. Support data reconciliation and data structure inquiry resolution. Liaise cross-functionally to facilitate creation of new test codes. Participate in the Clinical Study Team as an extended team member. Oversee and train in the use of DTS and other documents. Contribute to improvement initiatives as it relates to external data processes. Ensure study teams adhere to CDISC standards and regulatory requirements. Process change requests to update existing DTS and improve templates for data harmonization. Provide external data management oversight to vendors and review eCRF/EDC builds as they relate to external data requirements. You will have solid clinical data science experience, with the ability to manage competing priorities and develop your team. Required qualifications include biomarker/imaging data experience, proficiency with SAS/CSV/XML, and strong regulatory knowledge (21 CFR Part 11, ICH-GCP, CDISC). Employment with ICON is contingent upon legal right to work in the country where the role is based.
Required Qualifications
- 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
- Employment with ICON is contingent upon having the legal right to work in the country where the role is based
Additional Requirements
- Legal right to work in the country of employment
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