Senior Statistical Programmer I

As an SDTM Statistical Programmer at ICON, you will be responsible for analyzing clinical trial data and supporting the statistical analysis process to ensure high-quality results. Your key responsibilities will include:

• Adhering to applicable SOPs, WIs, policies, and local regulatory requirements
• Reviewing and providing input into all trial set-up documentation
• Translating protocol and de-risking into detailed technical specifications and mapping documentation
• Creating Data Review Model (DRM) and SDTM datasets based on current standards
• Developing back-end edit checks, listings, and visualizations for risk-based central monitoring
• Quality checking of all clinical programming deliverables
• Performing unblinding and data-cut activities for reporting milestones and database locks
• Developing and validating electronic submission packages for regulatory compliance
• Supporting the development of standards and driving implementation within the organization

Qualifications required for this role include:

• Bachelors or Masters degree in Statistics, Mathematics, Computer Science, or a related field
• 4+ years of experience in statistical programming, preferably in a clinical research or pharmaceutical setting
• Strong proficiency in SAS programming and understanding of statistical concepts
• Excellent analytical and problem-solving skills with attention to detail
• Strong communication skills and ability to work collaboratively in a team environment

ICON offers a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, benefits include various annual leave entitlements, health insurance options, retirement planning offerings, and a Global Employee Assistance Programme. ICON is committed to providing an inclusive and accessible environment free of discrimination and harassment.

If you are interested in this role, even if you are unsure about meeting all requirements, it is encouraged to apply as you may be the ideal candidate for ICON. As an SDTM Statistical Programmer at ICON, you will be responsible for analyzing clinical trial data and supporting the statistical analysis process to ensure high-quality results. Your key responsibilities will include:

• Adhering to applicable SOPs, WIs, policies, and local regulatory requirements
• Reviewing and providing input into all trial set-up documentation
• Translating protocol and de-risking into detailed technical specifications and mapping documentation
• Creating Data Review Model (DRM) and SDTM datasets based on current standards
• Developing back-end edit checks, listings, and visualizations for risk-based central monitoring
• Quality checking of all clinical programming deliverables
• Performing unblinding and data-cut activities for reporting milestones and database locks
• Developing and validating electronic submission packages for regulatory compliance
• Supporting the development of standards and driving implementation within the organization

Qualifications required for this role include:

• Bachelors or Masters degree in Statistics, Mathematics, Computer Science, or a related field
• 4+ years of experience in statistical programming, preferably in a clinical research or pharmaceutical setting
• Strong proficiency in SAS programming and understanding of statistical concepts
• Excellent analytical and problem-solving skills with attention to detail
• Strong communication skills and ability to work collaboratively in a team environment

ICON offers a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, benefits include various annual leave entitlements, health insurance options, retirement planning offerings, and a Global Employee Assistance Programme. ICON is committed to providing an inclusive and accessible environment free of discrimination and harassment.

If you are interested in this role, even if you are unsure about meeting all requirements, it is encouraged to apply as you may be the ideal candidate for ICON.