Job Title: Senior Clinical Data Science Lead
Location: Not specified (onsite role)
Company: Not specified
About the Role:
The Senior Clinical Data Science Lead plays a pivotal role in Clinical Development, focusing on the delivery, structure, and integration of external data such as biomarkers, wearable devices, IRT, Imaging, and electronic clinical outcomes assessments (eCOA). This role will lead and support the Global Development Data Management team and serve as the main point of contact for overseeing external data quality control, standardization, and integration across line functions.
Key Responsibilities:
Oversee quality control and standardization of external clinical data sources.
Ensure proper integration of diverse data types including biomarkers, wearable device outputs, imaging, and eCOA data.
Act as the primary liaison with other departments for external data-related operations.
Provide strategic leadership to the Global Development Data Management team.
Required Knowledge, Skills, and Abilities:
Expertise in biomarker and/or imaging data for oncology and non-oncology clinical studies (preferred).
Proven experience working with multiple clinical data types and formats.
Strong understanding of managing clinical, biomarker, eCOA, and imaging data.
In-depth knowledge of regulatory requirements including 21 CFR Part 11, ICH-GCP Guidelines.
Proficiency in CDISC standards for data collection.
Advanced knowledge of data management processes and best industry practices.
Technical expertise in extracting data into SAS, CSV, and XML formats.
Experience Requirements:
Minimum of 8 years in external clinical data management or programming within the pharmaceutical, biotechnology, or health-related industry.
Strong understanding of database structures.
Education Requirements:
Bachelor’s degree in Biology, Computer Science, Programming, Data Management, or a related scientific/analytical discipline (or equivalent).
Additional Information:
Remote Work: Not available.
Freshers: Not eligible.
Applicants are encouraged to read the job description carefully before applying.
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