This job is with ICON plc, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
Key Areas Of Responsibility
• Lead statistical programming activities (SAS, Programming Specifications, Infrastructure).
• Oversee, mentor, and help develop group of internal Statistical Programmers and Consultants.
• Review CRFs and database specifications to ensure consistency with the study protocol and for the purpose collecting the data to meet the objectives defined in the statistical section of the clinical study protocol and Statistical Analysis Plan.
• Create analysis datasets from the clinical database and other data sources as outlined in the clinical study protocol and Statistical Analysis Plan.
• Generate tables, listings, and figures as specified in the Statistical Analysis Plan.
• Create ad hoc analyses and summaries as requested.
• Provide data cleaning support for the data management effort.
• Develop standardized SAS macros and utilities.
• Involved in the QC of all the deliverables created by programming and statistics (e.g. analysis data sets, output, the statistical section in the study report).
• Works under the guidance of the project Biostatistician.
• Build successful relationships and seamless interfaces at the protocol / project team level, and provide timely and effective communication to the study team / trial manager and Biostatistics leads.
• Provide input for the technical infrastructure of the statistic programming function.
• Develop and implement strategy for the improvement of productivity and standardizing of statistical programming activities.
• Assist in developing, applying and promoting consistent standards through standard processes and SOPs.
• Ensure guidelines and specifications regarding programming practices are followed, and ensure maintenance of appropriate documentation regarding lead and validation programming efforts.
• Interface closely with Biostatistics and Data Management on the project level.
• Able to work independently.
• Other Duties as assigned.
Requirements For The Position
• BS Degree in Computer Science, Information Management, Mathematics, Statistics, or a scientific discipline; or sufficient relevant experience with a minimum of 3 years of Statistical Programming knowledge in the device / pharma industry.
• Extensive experience with Base SAS, SAS/STAT, SAS Macro language, SAS/GRAPH, and in general excellent computer skills.
• Coding dictionary experience preferred.
• Strong communication skills, both verbal and written.
• Strong scientific background and understanding of clinical trials, pharmaceutical / device operations, and regulatory compliance.
• Practical knowledge of ICH, FDA, and GCP regulations and guidelines.
• Proven ability to take independent action to initiate process improvement, when needed.
• Proven ability to work in a matrix-like manner where cross-functional interaction is implicit.
• Proven ability to deliver on delegated work efficiently.
• Solid time-management skills to meet deliverables commensurate with a fast-paced environment.
• Well organized, able to multitask and prioritize competing tasks.
• Able to manage expectations with supervisors, peers and customers.
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 assessme
Location: Anywhere
Posted: Oct. 11, 2024, 4:25 p.m.
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