Job Summary

NoyMed CRO is on the lookout for experienced Mid-Senior Statistical Programmers to join our innovative team. Your strong communication skills and creative problem-solving mindset will be vital in delivering high-quality statistical programming solutions that drive successful project outcomes. Join us in making a meaningful impact in the world of clinical research!

Responsibilities

• Understand and conduct work consistent with GCP, ICH, 21 CFR part 11, internal SOPs and international regulatory requirements
• Lead, or perform a leading role in statistical programming activities to maintain project plan, track daily status updates and timelines within the team, ensure budget monitoring and adherence, as well as efficient communication methodology with clients
• Interact with the project statistician and guide other programmers participating in a project completion
• Responsible for accuracy, traceability, and reproducibility of data, quality, and reliability of deliverables of the project
• Develop and validate specifications for SDTM datasets and analysis datasets following SDTM and ADaM Implementation Guides, statistical analysis plans
• Develop and validate algorithms and programs to create datasets
• Develop complex SAS macros in order to automate and standardize routine processes
• Develop, upgrade, and validate the programs to produce Tables, Listings, and Graphs
• Act as a mentor and tutor for junior programmers

Skills

• SAS (Advanced Macros, PROC SQL, Reporting)
• CDISC Standards (SDTM, ADaM)
• Regulatory submission support (FDA, EMEA)
• TLF development & QC validation
• Cross-functional and vendor collaboration

Required Qualifications

• At least Bachelor's degree in Computer Science or a related field
• 5+ years’ of relevant work experience
• Excellent English skills
• Strong sense of discipline and responsibility
• In-depth understanding of data collection, data flow management, data quality, data extraction, and data standards with solid knowledge of CDISC standards for CDASH, SDTM, and ADaM
• Experience with multiple programming languages (SAS programming language, R, SQL, or other languages/tools as required, SAS Certification desired), including the creation of data entry and query screens/processes and data quality checks
• In-depth knowledge of research processes, clinical operations, and data quality management
• Strong attention to detail and demonstrated proficiency in quantitative and qualitative analyses
• Ability to manage multiple projects, tasks, and priorities; work independently with minimal supervision and execute tasks to completion without a great deal of direction
• Experience in training users in the operation of clinical trial software and tools
• Ability to exercise judgment, initiative, and resourcefulness in making decisions in consultation with clinical research personnel, and independently if necessary
• Demonstrate strong teamwork and organizational skills; outstanding interpersonal and communication skills

Work Location: Remote