Job Description

This role is for a Clinical Data Analyst with EXTENSIVE SAS Experience. Candidates must have hands on, technical experience and knowledge of utilising SAS within Clinical Data Analysis for Clinical Trials in the Biotech/Pharmaceutical Industry.

The client are growing rapidly, and looking for support as they gear up for NDA Submission.

Contractor - Clinical Data Analyst

About the Company:

We are a clinical-stage precision oncology organization dedicated to developing novel targeted therapies that address frontier challenges in cancer treatment. Our robust R&D pipeline focuses on innovative inhibitors designed to suppress oncogenic variants and enhance combination treatment strategies. Join a team committed to delivering impactful therapies for patients with cancers linked to critical signaling pathways.

The Opportunity:

As a Clinical Data Analyst, you will support the Clinical Data Programming function by:

• Collaborating with data managers, statistical programmers, biostatistics, clinical operations, and external vendors to review and finalize data transfer specifications.
• Ensuring data is received, validated, and meets data integrity standards.
• Creating or updating data transfer programs and running them according to timelines while adhering to specifications.
• Participating in the development of SAS programming standards, SOPs, and work instructions, including validation and documentation processes.
• Contributing to SAS macro program development and enhancing existing macros to improve project lifecycle efficiency.
• Reviewing vendor data transfer specifications, including variable lists and attributes.
• Following Clinical Data Programming guidelines and SAS programming best practices.
• Monitoring automated jobs and logs.
• Running Data Review Listings (DRLs) and Study Health Metrics (SHMs) per timelines.
• Conducting peer reviews of Data Review Listings and reconciliation reports.
• Using sFTP/FTP clients or vendor portals to manage data downloads and repository postings.
• Developing new DRLs or study-level reconciliation programs.
• Supporting and guiding team members within the Clinical Data Programming function.
• Collaborating with data managers to generate outputs for data cleaning, enhancing data integrity, and ensuring timely and accurate deliverables.
• Addressing data issues identified by cross-functional teams.
• Utilizing knowledge of CRF annotation, FDA regulations (CDISC, 21 CFR Part 11, ICH, GCP), and other regulatory requirements for submissions.

Required Skills, Experience, and Education:

• MS, BS/BA degree, or equivalent qualification relevant to the field.
• Proficiency in custom reporting using Business Objects, SAS, Crystal Reports, and Medidata Rave Study Build.
• 7+ years of experience in Phases I, II, and III oncology clinical trial studies.
• Minimum 5 years of oncology-specific experience.
• Strong multitasking, prioritization, problem-solving, and collaboration skills.
• Effective written and oral communication abilities.

Preferred Skills:

• SAS certification, experience with Spotfire, Tableau, Power BI, or Windows batch scripting.
• Python programming knowledge is a plus.

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