Clinical Data Analyst

Bayside Solutions; California; Híbrido; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Communication skills

Multitasking

Team guidance

Regulatory awareness

Educación

MS/BS in related field

Herramientas

SAS

Crystal Reports

Business Objects

Medidata Rave Study Build

Spotfire

Tableau

Power BI

Windows batch scripting

sFTP/FTP

Descripción del empleo

Location: Redwood City, CA - Hybrid Role

Duties and 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.

Requirements and 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.

Preferred Qualifications:

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

Desired Skills and Experience

Clinical data analysis and programming, SAS programming and macros, data transfer specifications and validation, vendor data integration, sFTP/FTP and vendor portals, data integrity and cleaning, data reconciliation, Data Review Listings (DRLs) and SHMs, automated job monitoring and log review, peer review, program validation and documentation, SAS standards and SOP development, Business Objects, Crystal Reports, Medidata Rave Study Build, CRF annotation, CDISC standards, FDA regulations and 21 CFR Part 11, ICH/GCP guidelines, NDA submission support, 7+ years of Phase I-III clinical trial experience including 5+ years in oncology, cross-functional collaboration and team guidance, troubleshooting and data issue resolution, prioritization and multitasking, written and verbal communication, continuous improvement, SAS certification preferred, Spotfire/Tableau/Power BI and Windows batch scripting preferred, Python programming 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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