Job Title: Clinical Data Analyst
Location: Remote
Pay: $50/hr
Job Summary:
Seeking an experienced Clinical Data Analyst to support oncology clinical trials through SAS programming, clinical data transfers, data validation, reconciliation, and data quality management.
Key Responsibilities
- Review and approve data transfer specifications from external vendors.
- Create, update, and execute SAS data transfer programs.
- Validate incoming clinical data to ensure data integrity and accuracy.
- Review vendor specifications, variable lists, and data attributes.
- Monitor automated jobs and review program logs.
- Generate Data Review Listings (DRLs) and perform Study Health Monitoring (SHM) activities.
- Conduct peer reviews of data review listings and reconciliation reports.
- Transfer data using sFTP/FTP clients and vendor portals.
- Develop and maintain data review and reconciliation programs.
- Support and guide Clinical Data Programmers and team members.
- Develop and maintain SAS macros, programming standards, SOPs, and work instructions.
- Collaborate with Data Management, Biostatistics, Statistical Programming, Clinical Operations, and external vendors.
- Identify and resolve data issues to support data cleaning and data quality.
- Ensure compliance with CDISC, GCP, ICH guidelines, 21 CFR Part 11, and applicable FDA regulations.
- Support CRF annotation, program validation, documentation, and regulatory submissions.
Requirements
- Bachelor's or Master's degree in a relevant field or equivalent qualification.
- 7+ years of relevant clinical trial experience.
- Minimum 5 years of oncology clinical trial experience.
- Experience working on Phase I, II, and III oncology clinical trials.
- Strong SAS programming and clinical data transfer experience.
- Experience with Medidata Rave Study Build.
- Experience with Business Objects, SAS, and Crystal Reports.
- Knowledge of data validation, reconciliation, and data integrity.
- Understanding of CDISC, GCP, ICH guidelines, 21 CFR Part 11, and FDA regulations.
- Experience using sFTP/FTP clients or vendor portals for data transfers.
- Strong analytical, troubleshooting, communication, and collaboration skills.
Preferred Skills
- SAS programming certification.
- Experience with Spotfire, Tableau, or Power BI.
- Knowledge of Windows batch scripting.
- Python programming experience.
Contact to Apply:
Name: Pavani Samboju
Email:
pavani.samboju@intellectt.com
Phone: 732 993 4972INTELLECTT INCBenefits:
Eligible employees may have access to benefits offered by Intellectt Inc. in accordance with the applicable benefit plans and eligibility requirements.
Equal Employment Opportunity:
Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.