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Job Description
Structured overview of role & requirementsAbout This Role
Lead clinical data science setup and execution for clinical trials including eCRF design, Data Flow Plans, and Blinding Plans.
Ensure quality control and compliance of SDTM and ADaM deliverables, manage submission packages, and generate TFL according to standards.
Manage stakeholder coordination, CRO/vendor collaboration, trial execution oversight, and drive methodological and operational improvements.
Minimum Requirements
Bachelor's or Master's degree in life sciences, natural sciences, engineering, or equivalent.
3-5 years statistical programming experience; preferably 1 year in pharmaceutical industry or equivalent.
Extensive programming expertise in SAS or R for clinical trial data analysis and reporting.
Strong knowledge of drug development processes, clinical database technologies, data standards, and regulatory guidelines (GxP).
Ideal Candidate Profile
Experienced in bridging clinical data programming with clinical development operational needs within trial squads.
Capable of managing multiple simultaneous priorities with strong planning, coordination, and communication skills.
Demonstrated ability to lead quality control for clinical data submissions and engage effectively across multinational and cross-functional teams.