Senior Clinical SAS Programmer

Bayside Solutions; Fremont (CA); Hybrid; USD 124,000 - 146,000; Full time

Job summary

A leading company in the biotech field is seeking a Senior Clinical SAS Programmer responsible for managing and ensuring the integrity of clinical trial data. The role involves collaboration with multiple teams to create data transfer programs and supporting Clinical Data Programmers. Candidates with extensive oncology experience and clinical SAS programming skills are preferred for this hybrid position based in Redwood City, CA.

Qualifications

• 7+ years of experience in clinical trial studies.
• 5+ years of oncology experience required.
• Experience with custom reporting and SAS programming in biotech/pharma.

Responsibilities

• Collaborate with data managers and external vendors to ensure data integrity.
• Create and run data transfer programs based on specifications.
• Support Clinical Data Programmers and participate in SAS programming standards.

Skills

Clinical SAS programming

Oncology

Data Management

Multi-tasking

Communication

Education

MS, BS/BA degree

Tools

Business Objects

SAS

Crystal Reports

Medidata Rave

Python

Job description

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This range is provided by Bayside Solutions. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$60.00/hr - $70.00/hr

Senior Clinical SAS Programmer

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
• Clinical SAS programming experience within biotech/pharma is required
• 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.

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

Senior Clinical SAS Programmer

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
• Clinical SAS programming experience within biotech/pharma is required
• 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.

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

Desired Skills and Experience

Clinical SAS 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

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Analyst, Information Technology, and Science

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