20367 - Clinical Programming Manager

Job description:

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