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Job Type

Full Time

Job Description

  • Convert and standardize clinical datasets originating in OMOP format into SDTM format according to CDISC regulatory submission guidelines. Data harmonization and -
  • Design the ETL (Extract, Transform, Load) process for

    clinical datasets

    . -

  • Implement the ETL process using appropriate technical tools and languages .
  • OHDSI recommendation on ETL implementation, experience with SQL builders, Python and R is advantageous. -

  • Organize and clean complex clinical trial data including labs, adverse events, vital signs, and other trial-related datasets into consistent, review-ready tables.-
  • Working exp on white rabbit -preferred
  • Collaborate closely with clinical operations, statistical programming teams, and regulatory stakeholders to ensure data quality and compliance.
  • Develop and maintain automated pipelines and workflows for efficient data transformation and validation.
  • Provide expert input on clinical data standards and advise on best practices for data curation and submission readiness.
  • Support regulatory submission processes by ensuring timely and accurate delivery of SDTM datasets.
  • Act as a bridge between raw real-world data sources and regulatory requirements, translating technical challenges into actionable solutions
  • Participate actively in all aspects of quality control to ensure the accuracy and integrity of data throughout the ETL and conversion process.
  • Soft skills: fluent in English, problem-solving mentality, detail-oriented person, good communication and interpersonal skills, fast learner
  • Additional (not must have): previous work/experiences on statistical programming, genomic data, NLP applications on healthcare datasets, data visualization

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Wenger & Watson

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