Oncology Clinical Data Analyst (Hybrid) - SAS & Data Validation

Bayside Solutions; California; Hybrid; USD 120,000 - 180,000; Full time

Job summary

Bayside Solutions, Inc. in Redwood City, CA is seeking an experienced Clinical Data Programmer to collaborate with data managers, biostatisticians, clinical operations, and vendors.

You will review data transfer specifications, create and run transfer programs, validate data integrity, and ensure timely, accurate outputs using SAS and related tools. The role requires 7+ years in Phases I-III oncology trials, a MS/BS in a relevant field, and proficiency with Medidata Rave Study Build, SAS, CDISC

Qualifications

• 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.

Responsibilities

• Collaborate with data managers, statistical programmers, biostatistics, clinical operations, and external vendors to review and sign off on data transfer specifications and transfer data from external sources.
• 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.

Skills

Communication skills

Multitasking

Team guidance

Regulatory awareness

Education

MS/BS in related field

Tools

SAS

Crystal Reports

Business Objects

Medidata Rave Study Build

Spotfire

Tableau

Power BI

Windows batch scripting

sFTP/FTP

Job description

Bayside Solutions, Inc. in Redwood City, CA is seeking an experienced Clinical Data Programmer to collaborate with data managers, biostatisticians, clinical operations, and vendors.

You will review data transfer specifications, create and run transfer programs, validate data integrity, and ensure timely, accurate outputs using SAS and related tools. The role requires 7+ years in Phases I-III oncology trials, a MS/BS in a relevant field, and proficiency with Medidata Rave Study Build, SAS, CDISC