Senior Statistical Programmer I

SDTM Programmer

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We are currently seeking a Statistical Programmer (SDTM Oversight activities) to join our diverse and dynamic team.

As a SDTM Statistical Programmer at ICON, you will play a crucial role in analyzing clinical trial data and supporting the statistical analysis process to ensure high-quality results. You will contribute to the success of our clinical studies by developing and validating statistical programs, collaborating with biostatisticians, and ensuring compliance with regulatory standards.

What You Will Be Doing:

• Services rendered will adhere to applicable SOPs, WIs, policies, local regulatory requirements,  etc.
• Review and provide input into all trial set-up documentation
• Translate protocol and any applicable de-risking into the creation and maintenance of detailed technical specifications, mapping documentation including aCRF, data transfer agreements, as applicable, etc.
• Creation of Data Review Model (DRM) based on current standards and SDTM datasets based on current SDTM standards
• Creation of back-end edit checks, listings, and visualizations to support risk-based central monitoring, e.g., Quality Tolerance Limits (QTLs), Critical to Quality (CtQ), etc., and ongoing clinical and safety data review
• QC of all clinical programming deliverables
• Perform unblinding, data-cut activities for planned reporting milestones and database locks
• Development and validation of electronic submission packages that comply with submission requirements from FDA, EMEA, and other regulatory agencies as needed
• Support the development of standards and drive implementation within the organization

Your Profile:

• Bachelor’s or Master’s 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, with a solid understanding of statistical concepts and methodologies.
• Excellent analytical and problem-solving skills, with a keen attention to detail.
• Strong communication skills, with the ability to work collaboratively in a team environment and effectively convey complex information.

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply