Job Description

OverviewThe Senior Clinical Data Science Lead will play a critical role in Clinical Development through ensuring the delivery of appropriately structured external data, including but not limited to data from biomarkers, wearable devices, IRT, Imaging and Electronic clinical outcomes assessment - eCOA. The Senior Clinical Data Science Lead will be responsible for effectively leading and supporting the Global Development Data Management team by serving as the primary contact to other line functions to oversee external data quality control, standardization, and integration for external data.ResponsibilitiesExpertise in biomarker data types and/or Imaging data for oncology and nononcology studies is preferred List knowledge, skills, and abilities required to perform the job.List any preferred job requirements as well.

• 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

• Minimum of 8 years of external clinical data management/programming experience in biotechnology, pharmaceutical or health related industry and strong knowledge of database structures.

• BS Major/ Minor (Biology, Computer Science, programming, data management, scientific or analytic discipline or equivalent)

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