Data Scientist (Clinical)

Designation:

We are seeking a highly skilled Data Scientist with strong expertise in clinical data standards and regulatory submission formats. The ideal candidate will have hands on experience working with OMOP and SDTM data models, capable of converting raw, heterogeneous clinical datasets into standardized formats required for regulatory submissions to agencies such as the FDA and PMDA.

Key Responsibilities

• Convert and standardize clinical datasets originating in OMOP format into SDTM format according to CDISC regulatory submission guidelines.
• 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

navya_b@trigent.com