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Clinical Research Programmer
1 week ago
Altis Recruitment is partnering with a leading full-service Contract Research Organization (CRO) to find a highly skilled Clinical Research Programmer.
In this role, you will be responsible for ensuring the quality and efficiency of statistical programming deliverables, leading projects, and developing and validating CDISC-compliant datasets.
As a key member of the team, you will contribute to regulatory submissions and have opportunities to advance your career in a supportive and collaborative environment.
This position offers the flexibility to work remotely from anywhere in Canada or the United States.
Key Responsibilities:
- Lead and resolve day-to-day programming challenges, driving quality and efficiency.
- Manage assigned projects, ensuring timely and high-quality deliverables, building client trust.
- Develop and QC SDTM and ADaM dataset specifications for clinical study reports (CSRs), ISS, and ISE.
- Program and validate SDTM and ADaM datasets, ensuring CDISC compliance.
- Perform comprehensive quality control of statistical tables, listings, and graphs (TLGs).
- Create and QC SDTM and ADaM define.xml files.
- Contribute to regulatory submission activities.
- Develop and maintain programming utilities and macros.
- Implement complex data integrity checks.
- Adhere to company and sponsor SOPs and guidelines.
- Document and archive clinical trial data and programming information.
Qualifications:
- A Master's degree in statistics, biostatistics, epidemiology, bioinformatics, mathematics, or computer sciences.
- 4+ years of experience in clinical trial statistical programming and/or data analysis, preferably within a CRO.
- Advanced proficiency in SAS.
- A proven track record of high performance and strong capabilities as a Statistical Programmer.
- Experience with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Project).
- Strong problem-solving, planning, organizational, and time management skills.
Benefits:
- A competitive salary.
- A comprehensive benefits package, including medical, dental, vision, pension, and life insurance.
- Discretionary bonuses and salary increases.
- Paid vacation, sick days, and floater days.
- A fitness subsidy.