Senior Statistical Programmer I

PRA International; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

A leading company in clinical research seeks a Senior Statistical Programmer accountable for statistical programming deliverables in clinical studies. This role emphasizes high-quality programming, adherence to compliance, and collaboration with stakeholders. Candidates should have significant SAS programming experience and knowledge of relevant standards like CDISC and ADaM.

Benefits

Various annual leave entitlements

Comprehensive health insurance offerings

Competitive retirement planning

Global Employee Assistance Programme

Life assurance

Flexible optional benefits

Qualifications

• 7 years SAS programming experience in a clinical trial or MS with 5 years experience.
• Expertise in SAS and clinical trial programming.
• In-depth understanding of CDISC standards.

Responsibilities

• Develop and validate statistical programming deliverables for clinical studies.
• Conduct statistical programming and simulations to support clinical decisions.
• Support medical monitoring and quality control processes.

Skills

SAS programming

Statistical programming

Quality assurance

Interpersonal skills

Negotiation

ADaM standards

CDISC standards

Education

BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering

MS in related field

Tools

JReview

R

Job description

Overview

The Senior Statistical Programmer will be accountable for statistical programming deliverables in on clinical studies. In this role, you will report to the Sr. Director of Statistical Programming.

You will develop and validate statistical programming deliverables for clinical studies, ensuring that they meet quality, compliance, and timeliness requirements. The role requires collaboration with various stakeholders, including Biostatistics, Clinical Research, Data Management, and so on.

Responsibilities

What you will be doing:

• Be responsible for statistical programming deliverables in multi-disciplinary interactions
• Support medical monitoring by developing/updating TLFs using JReview system
• Provide development, review and approval for statistical programming documents
• Have In-depth understanding of CDISC standards (SDTM, ADaM, Define.xml, etc.) and apply corresponding knowledge to develop ADaM specifications, SAS programs and review regulatory electronic submission packages
• Conduct statistical programming and/or statistical simulations to support clinical decision making, regulatory interaction, and publications
• Support statistical programming quality control process

Qualifications

You are:

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 7 years SAS programming experience in a clinical trial environment; or MS with a minimum of 5 years relevant work experience
• Expertise in SAS and clinical trial programming; Experience in R is a plus
• Superior knowledge and significant experience in setting strategy and developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) using global and TA standards based on quality, compliance and timeliness requirements
• US of worldwide drug regulatory application submission experience including the development of electronic submission deliverables
• Experience in CDISC and ADaM standards
• Demonstrated success in the assurance of deliverable quality and process compliance
• Excellent interpersonal skills and ability to negotiate and collaborate effectively
• Recent experience working in the field of oncology preferred but not required
• Experience developing and implementing statistical programming standards preferred but not required
• Experience developing JReview reports to support medical monitoring preferred but not required

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/benefitsAt 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, 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 through the form below. https://careers.iconplc.com/reasonable-accommodationsInterested 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.