Clinical Data Analyst / Programming
The Opportunity
In this position, you will be working for the Company’s Clinical Data Programming function, specifically:
- Collaborate with data managers, statistical programmers, biostatistics, clinical operations, and external vendors to review, sign off on the data transfer specifications, and transfer data from external sources, ensuring data is received and validated for data integrity.
- Create or update data transfer programs and run them based on the timeline and check against data transfer specifications.
- Review the data transfer specifications from vendors with variable lists and attributes.
- Follow Clinical Data Programming guidelines and best practices for SAS programming.
- Monitor automated jobs and their logs.
- Run DRLs and SHMs based on the timelines.
- Peer review Data Review Listings or Reconciliation reports.
- Ability to use sFTP/FTP clients or vendor portals to download the data and post it to repository.
- Create new DRLs or study level Data Review Listings or reconciliation programs.
- Should be able to support and guide Clinical Data Programmer and team members.
- Participate in the development and implementation of SAS programming standards, SOPs, and work instructions, including program validation and documentation.
- Work with data managers and generate outputs to support data cleaning, enhance data integrity, and ensure timely, targeted, and accurate deliverables.
- Address data issues identified by cross-functional team members.
- Contribute to the development of SAS macro programs and participate in modifying existing SAS macro programs to improve efficiency throughout the project life cycle.
- Work experience in using CRF-Annotation, FDA regulations such as CDISC, 21 CFR Part 11, ICH, GCP guidelines, and other regulatory submissions to the NDA.
Required Skills, Experience and Education:
- MS, BS/BA degree or other suitable qualification with relevance to the field.
- Custom reporting using Business Objects, SAS, Crystal Reports and understanding of Medidata Rave Study Build required.
- Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute goals as a member of an interdisciplinary team is extremely important.
- Should have real-time 7+ years of work experience in Phases I, II, and III oncology clinical trial studies.
- Min 5 years of oncology experience needed.
- Adaptive learner, initiative-taker, effective troubleshooter, and good at resolving data issues, committed to continuous learning and improvement, and should be a collaborator.
- Effective written and oral communication skills required.
Preferred Skills:
- Possessing SAS certification, work experience in Spotfire or Tableau or Power BI and windows batch script is preferred.
Python programming experience