Principal Statistical Programmer

ICON is looking for a Principal Statitical Programmer. This position is responsible for processing clinical data required for statistical analysis of Phase I — III clinical trials, leading project teams, and consistently leads of project teams.

What you will be doing:

• Conduct statistical programming work of clinical data using SAS Software.
• Ensure that all programs, outputs and documentation are consistent with ICH guidelines and are conducted in compliance with company SOPs.
• Generate analysis datasets according to CDISC standard and SAP
• Implement analysis methods according to SAP, and produce summary tables, graphs and data listings using SAS; Conduct adhoc analyses.
• Validate programs and associated results produced by other programming colleagues.
• Participate in TLF shell preparation and review, and assist statistician for SAP preparation
• Run CDISC validation programs e.g. OpenCDISC reports to ensure ADaM datasets are CDISC compliant   
• Develop standard SAS macros for efficient analyses of clinical data supervised by Programming management
• Participate in the review of 'Statistical Analysis Plan' and other documents essential to the conduct of statistical programming work for clinical trials;
• Work with Clinical Research Organizations, as required, to participate in the oversight and management of programming activities to help ensure quality, timeline and deliverable are met;
• Work independently to program for individual studies with minimum supervision
• Function as a Lead programmer for a compound or a group of studies performing the following functions:
  • Maintain the overall timeline for his/her studies; Maintain the programming standards for his/her studies; Review standard macros used; Review standard datasets used; Discuss need for programming resources for their group of studies; Mentor/Train junior programmers on internal systems and standards as they work on studies within their area; Assist Junior programmers in new study set-up to help identify similar studies; Review Production area after study programming is complete to make sure datasets, programs, and outputs are properly stored; Check that the validation summary reports are clean of errors and warnings, and show proper documentation of SAS programs
  • Review individual study CDISC validation output
• Act as a Programming lead for a submission project under supervision of Programming management
• Serve as a mentor to junior programmers and as an expert to provide recommendations and solutions to complex problems

You are:

• BA/BS degree (MS degree in statistics or computer sciences is desired);
• Minimum 8 years of programming experience using SAS/Base/Macro/GRAPH in the biopharmaceutical and/or CRO industries;
• Data Management experience including CDISC standard is highly desirable;
• Good SAS programming skills and attention to detail are essential;
• Demonstrated knowledge of regulatory guidelines, including electronic submission standards;
• Strong organizational, time management, communication and project coordination and leadership skills;
• Must be able to work well under timeline pressure.
• Must be able to work on multiple tasks while coordinating others at the same time
• Demonstrate experience serving as a mentor to junior programmers and as an expert to provide recommendations and solutions to complex problems

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 maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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.