- Develop and implement data cleaning and reporting solutions to ensure quality and timely delivery of study data, metrics and visualizations as per data review plans.
- Create and maintain documentation for all reporting deliverables throughout the study lifecycle.
- Build a library of reusable data checks in collaboration with data engineers and configuration specialists.
- Partner with cross-functional teams to define business rules and establish an automated check library across therapeutic areas.
- Ensure compliance with SOPs and work practices.
- Act as a technical resource in developing data analytics for data validation and cleaning.
- Support knowledge sharing and training on reporting tools to ensure data accuracy and integrity.
- Provide programming expertise to enhance data quality and create tools, macros, and libraries for efficient data review.
- Develop and test data review listings and maintain operational excellence through collaboration with clinical data management and medical reviewers.
- Drive innovation and process improvement in reporting and data management practices.
Core Strength:
- Bachelors degree in computer science, Statistics, Biostatistics, Mathematics, Biology or a related health field or equivalent experience.
- Good understanding of the drug development process and regulatory data standards (CDISC, SDTM preferred).
- Minimum 2 plus years of experience in developing programming listings and visualizations using tools such as Veeva CDB, JReview, or Elluminate (Elluminate experience preferred).
- Proficient in programming languages such as CQL, SQL, SAS, R, or Python.
- Familiar with clinical database systems (e.g., Metadata Rave, Veeva, InForm).
- Skilled in using Microsoft Office tools (Word, Excel, Outlook).
- Strong understanding of clinical trial terminology.
- Able to work independently in a fast-paced environment, demonstrating initiative and adherence to deadlines.