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Job Description
Structured overview of role & requirementsAbout This Role
Manage and deliver statistical programming outputs including SDTM and ADaM datasets, annotated CRFs, and TFLs in compliance with regulatory standards.
Support trial setup and documentation activities such as developing eCRFs, metadata specs, Define.xml, and Clinical Study Reports.
Collaborate with internal/external stakeholders and contribute to process optimization, training, and adherence to GCP/GDP/GPP standards.
Minimum Requirements
Bachelor's or Master's degree in life sciences, natural sciences, engineering, or equivalent.
2-3 years programming experience, preferably with biological data or equivalent practical knowledge.
Proficiency in SAS or R programming languages.
Work Experience Required: 2-3 years of programming experience; Notice Period: Not explicitly mentioned in the JD.
Ideal Candidate Profile
Experienced in clinical trial statistical programming within a multinational, cross-functional environment.
Strong technical expertise in clinical database technologies and data models, capable of managing multiple variable workloads independently.
Comfortable communicating complex technical issues with diverse stakeholders and supporting process and quality improvements in clinical data science.
