
חדש באתר! העלו קורות חיים אנונימיים לאתר ואפשרו למעסיקים לפנות אליכם!
We are seeking expert Full Remote Clinical Programmer Manager (SDTM/CDISC) to lead data quality assurance and regulatory conversion planning for global clinical trials.
Responsibilities
Provide input for budget planning.Oversee contingent workers and external vendors
provide training as needed.Manage programming deliverables at the project level, ensuring quality and on-time delivery
Support CDISC-based e-submissions by developing, reviewing, and validating SAS macros and programs
Maintain strong knowledge of statistical models used in efficacy data analysis
Standardize clinical programming deliverables within projects
Develop and extend clinical programming methods to solve complex problems
Define Case Report Form (CRF) specifications in compliance with SDTM guidelines and lead cross-functional reviews
Define specifications for external (non-CRF) data per Biometrics standards
Ensure study databases meet requirements through User Acceptance Testing (UAT)
Manage day-to-day clinical and operational data receipt and handling according to study timelines
Program SAS/SQL clinical and operational reports and listings
Ensure programming processes meet quality standards and regulatory
Build and maintain positive partnerships with CROs to ensure high-quality deliverables
Act as the primary contact for assigned studies, coordinating with local departments and procedures
Support communication, collaboration, and prioritization within the department
Requirements
Bachelor’s, Master’s, or PhD in Science, Statistics, IT, or related field - Must
Minimum 5 years (Bachelor’s) or 4 years (Master’s) experience in pharmaceutical or clinical programming - Must
Experience with SDTM, ADaM, and CDISC guidelines preferred
Advanced SAS programming skills including development and quality control of integrated analyses
Knowledge of drug development regulations across multiple therapeutic areas
Strong problem-solving skills and ability to contribute to strategy
Excellent communication skills and ability to work effectively in global, multicultural teams
Ability to manage multiple projects independently.Detail-oriented with strong knowledge of CDISC standards
Why should you join us?
Recognized among Israel's top 100 best places to work for, four years in a row
Be part of a company that is a globally recognized leader in Quality Engineering
Experience our team spirit, working with real people, and solving real challenges
Work with Senior Specialists and Practice Experts
Nurture your personal and professional growth through tailored career paths
Dive into interesting projects using cutting-edge technology designed by and for Quality Engineers
Enjoy unique placement opportunities worldwide
We believe in a workplace culture that values open communication and fairness, encouraging our employees to feel seen, supported, and empowered to realize their full potential