Senior Clinical Data Analyst

Senior Clinical Data Analyst

W2 Contract

Salary Range: $124,800 - $145,600 per year

Location: Redwood City, CA - Hybrid Role

Job Summary:

As a Senior Clinical Data Manager, you will be responsible for all aspects of the data management process, from developing project documentation, system set-up, User Acceptance Testing (UAT), and routine data review through database lock of clinical trials.

Duties and Responsibilities:

• Collaborate with data managers, statistical programmers, biostatistics, clinical operations, and external vendors to review, sign off on data transfer specifications, and transfer data from external sources, ensuring data is received and validated for data integrity.
• Create or update data transfer programs, 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 and Reconciliation reports.
• Use sFTP/FTP clients or vendor portals to download and post the data to a repository.
• Create new DRLs or study level Data Review Listings or reconciliation programs.
• Support and guide Clinical Data Programmers and team members.
• Participate in developing and implementing 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 modify existing SAS macro programs to improve efficiency throughout the project life cycle.

Requirements and Qualifications:

• MS, BS/BA degree or other suitable qualification
• 7 years of work experience in Phases I, II, and III oncology clinical trial studies
• At least 5 years of oncology experience
• Experience with custom reporting using Business Objects, SAS, Crystal Reports, and an understanding of Medidata Rave Study Build is required.
• Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute goals as a member of an interdisciplinary team
• Adaptive learner, initiative-taker, effective troubleshooter, and good at resolving data issues, committed to continuous learning and improvement
• Effective written and oral communication skills
• Work experience using CRF-Annotation, FDA regulations such as CDISC, 21 CFR Part 11, ICH, GCP guidelines, and other regulatory submissions to the NDA.
• A SAS certification and work experience in Spotfire, Tableau, or PowerBI and Windows batch scripting is preferred.
• Python programming experience is a plus.

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

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Desired Skills and Experience

Clinical data programming, clinical trial studies, oncology, Business Objects, SAS, Crystal Reports, Medidata Rave Study Build, CRF-Annotation, FDA regulation, ICH guidelines, GCP guidelines, Spotfire, Tableau, PowerBI, Windows batch, Python