Clinical Programmer - SDTM (Advanced)

Pharmaceutical Research Associates, Inc; United Kingdom; On-site; GBP 40,000 - 80,000; Full time

Job description

Overview

As a Clinical Programmer - SDTM, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities

Responsibilities include:

• Providing expertise, delivery and oversight of clinical programming deliverables from study set-up to submission-ready tabulation packages.
• Providing specifications for data models to be used for quality review and for final data model (SDTM); design mapping algorithms for non-standard conversions.
• Ensuring quality review of datasets (e.g. Pinnacle 21 compliance checking); ensuring datasets are available for stakeholder use (medical review, central monitoring, adaptive designs) and compliant for database lock.
• Program, or oversee Programming of, quality review checks and reports for use by Data Managers and other team members.
• Develop and maintain working knowledge and expertise in programming languages utilized in clinical programming (SAS, SQL).
• Creation of submission-ready SDTM packages for FDA or other regulatory authorities.
• Acquiring and maintaining working knowledge in data collection tools such as Medidata Rave, LSAF, Pinnacle 21.
• Working to CDISC standards such as SDTM, CDASH, Controlled Terminology and define.xml.

Qualifications

You are:

• Technically capable, a strong communicator, highly organized and possess first class project management skills.
• Bachelors Degree or higher/equivalent in Computer Science, Data Science, Data Engineering, Mathematics or another relevant scientific field.
• Clinical Programming experience and experience working on a clinical trial.
• Expert knowledge of SAS Programming, Define.xml, SDTM aCRF, cSDRGs.
• Expert knowledge of data structures.

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, TELUS Health, 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

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.

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.