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Protocol Intelligence
Data-driven signals on your job's competitivenessTier-1 employer, metro location, and mid-level experience amplify candidate competition despite niche skills.
Highly specialized clinical trials and SDTM/ADaM expertise limit cross-industry transferability.
Explicit 2-3 years plus mandatory SDTM/ADaM and regulatory skills enforce strict filters.
Job Description
Structured overview of role & requirementsAbout This Role
Manage key statistical programming tasks across clinical trials including SDTM and ADaM dataset finalization, annotated CRF preparation, and TFL creation in compliance with regulatory standards.
Support trial setup activities such as eCRF development, Data Flow Plans, metadata specs, mock TFLs, and Define.xml documentation.
Collaborate with internal and external stakeholders (CROs, regulatory authorities, scientific communities) to ensure seamless execution of clinical trials and contribute to process improvements, training, and change management.
Minimum Requirements
Bachelor's or Master's degree in life sciences, natural sciences, engineering, or equivalent.
2-3 years of programming experience, preferably with biological data or equivalent relevant practical experience.
Proficiency in SAS or R programming languages and experience with clinical database technologies and data models.
Fluency in English (written and spoken) and ability to communicate technical issues to diverse stakeholders.
Ideal Candidate Profile
Experienced in supporting clinical trial programming and data management throughout the clinical development lifecycle.
Able to operate effectively in a multinational and multidisciplinary team environment, collaborating across professional and regional borders.
Has strong analytical skills, accountability, and can manage variable workloads independently while adhering to Good Clinical Practice (GCP), GDP, and GPP standards.