Clinical Data Analyst

Salary Range: $114,400 - $135,200 per year

Location: Redwood City, CA - Onsite Role

• Collaborate with data managers, statistical programmers, biostatistics, clinical operations, and external vendors to review and 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 the repository.
• Create new DRLs or study-level Data Review Listings or reconciliation programs.
• Should be able to support and guide the 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.

• MS, BS/BA degree or other suitable qualification with relevance to the field.
• Custom reporting using Business Objects, SAS, Crystal Reports, and an understanding of Medidata Rave Study Build is required.
• Demonstrated ability to multitask, 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.

• Possessing SAS certification, work experience in Spotfire, Tableau, or Power BI, and Windows batch script is preferred.
• Python programming experience is a plus.

Clinical data analysis, Clinical data programming, SAS programming, SAS macros, SAS certification, Data transfer specifications, External data transfers, Data validation and data integrity, Clinical data review listings (DRLs), Study health metrics (SHMs), Data reconciliation, Automated job monitoring, Log review, sFTP/FTP data transfers, Vendor data integration, Clinical data repositories, Peer review of data outputs, Custom clinical reporting, Business Objects, Crystal Reports, Medidata Rave Study Build, CRF annotation, CDISC standards, FDA regulations, 21 CFR Part 11, ICH guidelines, GCP compliance, Regulatory submissions support (NDA), Oncology clinical trials, Phase I/II/III clinical trials, Cross-functional collaboration, Clinical data cleaning, Data issue resolution, SAS programming standards, SOP and work instruction development, Program validation and documentation, Statistical and clinical operations collaboration, Team mentorship and guidance, Spotfire, Tableau, Power BI, Windows batch scripting, Python programming, Strong communication skills, Multitasking and prioritization, Continuous improvement mindset

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at