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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. Senior Statistical Programmer SDTM SAS Programmer We are currently seeking a Senior Statistical Programmer IIto join our diverse and dynamic team. As a Senior Statistical Programmer I at ICON, you will play a vital role in the analysis and reporting of clinical trial data, ensuring the integrity and accuracy of statistical outputs. You will contribute to the advancement of our clinical studies by developing and validating complex statistical programs, collaborating closely with biostatisticians, and adhering to regulatory standards. What You Will Be Doing • Designing, developing, and validating SAS programs for statistical analysis and reporting of clinical trial data., • Working closely with biostatisticians to create comprehensive analysis plans and apply appropriate statistical methods., • Performing quality control checks and reviewing statistical outputs to ensure compliance with project specifications and regulatory guidelines., • Assisting in the preparation of statistical reports, presentations, and regulatory submissions to support clinical development programs., • Mentoring junior programmers and contributing to team development by sharing best practices and technical knowledge. Your Profile • Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, or a related field., • Significant experience in statistical programming building SDTM datasets, • Strong proficiency in SAS programming and a solid understanding of statistical concepts and methodologies., • Excellent analytical skills, attention to detail, and the ability to manage multiple projects simultaneously., • Strong communication and interpersonal skills, with the ability to work collaboratively within a multidisciplinary team., • Must have Oncology experience. 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 ___ 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 ___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 ___ to apply

Job Description The Lead Biostatistician / Statistical Programmer plays a key role in driving profitable growth by leading proposal development and project execution in alignment with the organization’s strategic objectives. This role partners closely with Client Partners to support proactive business development, deliver high-quality services to clients, and ensure project profitability. The Lead Biostatistician builds and maintains trusted advisor relationships with clients and internal teams, focusing on delivering client value and fostering long-term growth. They are responsible for developing and leading high-performing project teams, ensuring all work is conducted in compliance with internal SOPs, ICH guidelines, industry standards, and regulatory requirements. Key responsibilities include reviewing and approving all biostatistics documentation and statistical programming outputs, overseeing project budgets and timelines, and ensuring overall quality and consistency across assigned accounts. In addition, the Lead Biostatistician contributes to talent acquisition efforts and collaborates with Quality Management to establish and maintain standard operating procedures (SOPs) and training programs. They provide advanced statistical expertise in the planning and design of clinical trials and non-interventional studies (NIS), perform in-depth data analyses, and offer statistical guidance for study reporting. Responsibilities What you will do: • Provide strategic statistical guidance on study design, including statistical model selection, sample size calculations, and analysis planning across clinical trials and non-interventional studies (NIS)., • Lead the development and programming of statistical analyses, tables, figures, and listings (TFLs) using SAS, ensuring alignment with sponsor requirements and internal standards., • Generate and validate derived analysis datasets in compliance with CDISC ADaM standards., • Author, review, and ensure rigorous quality control (QC) of Statistical Analysis Plans (SAPs) and related statistical documentation., • Validate programming output (e.g., TFLs, datasets) generated by team members to ensure accuracy and consistency., • Provide expert statistical input to study documents, including Case Report Forms (CRFs), Data Management Plans (DMPs), and clinical protocols., • Oversee and ensure proper execution of randomization procedures., • Conduct and interpret meta-analyses using statistical results from multiple published studies, ensuring scientifically robust conclusions., • Lead the statistical review and interpretation of Clinical Study Reports (CSRs), ensuring alignment with the SAP and regulatory expectations., • Proactively prioritize and manage multiple studies and projects to meet timelines and client expectations, balancing resources and risk., • Serve as a primary statistical point of contact for internal and external stakeholders, providing clear, compliant, and insightful responses and guidance., • Ensure all statistical deliverables meet applicable regulatory standards (e.g., ICH, GCP), industry guidelines, and internal SOPs., • Foster and maintain trusted relationships with clients, leading communication on statistical matters and contributing to long-term collaboration., • Drive the continuous improvement and development of internal statistical programming practices, guidelines, and SOPs., • Mentor junior team members, contribute to training initiatives, and promote a high-performing, quality-focused team culture., • Serve as a domain expert, integrating clinical, statistical, and industry best practices to design tailored solutions for complex client needs., • Collaborate with cross-functional teams to deliver innovative, high-impact statistical strategies that align with client objectives. Requirements: Education • Master’s degree in Statistics, Biostatistics, or a related quantitative field is required with a minimum of 5-8 of practical experience., • PhD in a relevant field is highly preferred. Experienc e • Minimum 5–8 years of relevant experience in biostatistics, preferably in the pharmaceutical, CRO, or life sciences sector., • Solid experience with non-interventional / observational studies and Phase 3 or Phase 4 clinical trials., • Demonstrated experience working with CDISC standards (including SDTM and ADaM)., • Good knowledge of the industrial standards (CDISC, ICH E9, GCP), • Proficiency in SAS and R programming with a minimum of 5 years of experience with both software., • Prior experience acting as a client-facing lead statistician, including proposal support and study design., • Strong understanding of project management, including budget management, timelines, and resource allocation., • Experience mentoring or leading junior statisticians or project team members., • Ability to further develop programming standards and research methods Skills • Excellent communication skills (written and verbal) in English., • Ability to manage multiple studies and clients simultaneously., • Strong organizational skills and attention to detail., • High level of initiative, accountability, and professionalism., • Excellent skills and knowledge of MS Office and IT, • Sound numerical reasoning, • Highly analytical with a problem-solving approach Qualifications Career Level - IC4 About Us As a world leader in cloud solutions, Oracle uses tomorrow’s technology to tackle today’s challenges. We’ve partnered with industry-leaders in almost every sector—and continue to thrive after 40+ years of change by operating with integrity. We know that true innovation starts when everyone is empowered to contribute. That’s why we’re committed to growing an inclusive workforce that promotes opportunities for all. Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs. We’re committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing or by calling +1 888 404 2494 in the United States. Oracle is an Equal Employment Opportunity Employer. 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