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Bayside Solutions · 19 hours ago

Clinical Data Analyst

San Mateo County, CA

Contract

Onsite

Mid, Senior Level

$114K/yr - $135K/yr

7+ years exp

Bayside Solutions is a company seeking a Clinical Data Analyst to collaborate with various teams to ensure data integrity and manage data transfer specifications. The role involves creating and updating data transfer programs, monitoring data quality, and supporting clinical data programming efforts.

Information TechnologyStaffing AgencyTelecommunicationsVirtual Reality

Growth Opportunities

No H1B

Responsibilities

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

Qualification

SAS programmingClinical data analysisOncology clinical trialsData validationData transfer specificationsCustom reportingSAS certificationIntegrityMultitaskingPrioritizationContinuous improvement mindsetTeam mentorshipPython programmingSpotfireTableauPower BIWindows batch scriptingCross-functional collaborationEffective communication

Required

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