Senior Statistical Programmer needed. Develop & validate SAS programs for clinical trial analysis. 5+ yrs exp in statistical programming within pharma/CRO required. Master's degree preferred.
Transform Data into Evidence: Senior Statistical Programmer
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research, turning complex data into clear evidence that supports regulatory submissions and improves patient care.
We are seeking a skilled and analytical Senior Statistical Programmer I to join our Biometrics team. In this pivotal role, you will be at the heart of the statistical analysis process, developing and validating robust SAS programs that transform clinical trial data into reliable results. Your work will directly support the statistical analysis plans (SAPs), create datasets for regulatory submissions (e.g., SDTM, ADaM), and generate the tables, listings, and figures (TLFs) that form the backbone of clinical study reports. If you are a SAS expert with a passion for precision and a drive to contribute to scientific advancement, this is your opportunity to shape the evidence that defines new therapies.
Your Mission: The Architect of Clinical Data Analysis
As a Senior Statistical Programmer I, you will be a key technical contributor, ensuring the accuracy, efficiency, and regulatory compliance of the statistical programming deliverables for assigned clinical trials.
Key Responsibilities
1. Advanced SAS Programming & Validation
- Develop, debug, validate, and maintain complex SAS programs for the creation of analysis datasets (ADaM) and CDISC-compliant submission data (SDTM).
- Generate and validate statistical outputs, including Tables, Listings, and Figures (TLFs), in accordance with the Statistical Analysis Plan (SAP) and study protocols.
- Perform rigorous quality control (QC) checks on statistical outputs to ensure accuracy, consistency, and traceability.
2. Collaboration & Statistical Support
- Collaborate closely with Biostatisticians to understand analysis requirements, define programming specifications, and implement statistical methodology.
- Provide programming support for Integrated Summaries of Safety/Efficacy (ISS/ISE), ad-hoc analyses, and regulatory requests.
- Contribute to the development and review of CRF annotations, database specifications, and data review plans.
3. Process Excellence & Compliance
- Ensure all programming activities and deliverables comply with ICH guidelines, CDISC standards, and ICON SOPs.
- Contribute to process improvement initiatives by identifying efficiencies in programming workflows and advocating for best practices.
- Assist in the preparation of technical documentation for regulatory submissions and respond to audit/inspection queries.
Who You Are: The Ideal Candidate
You are a meticulous and experienced statistical programmer who combines deep technical SAS expertise with a solid understanding of clinical trial statistics. You thrive on solving complex data challenges and are committed to delivering high-quality, regulatory-ready outputs.
Your Required Profile:
- Bachelor’s or Master’s degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related field. A Master’s degree is strongly preferred.
- Minimum of 5+ years of hands-on statistical programming experience within the pharmaceutical, biotechnology, or CRO industry.
- Expert-level proficiency in SAS (Base, Macro, STAT, GRAPH) with a proven track record of developing and validating programs for clinical trial analysis.
- Strong understanding of CDISC standards (SDTM, ADaM) and the clinical drug development process.
- Excellent analytical, problem-solving, and organizational skills with an unwavering attention to detail.
- Strong written and verbal communication skills with the ability to collaborate effectively in a global, cross-functional team environment.
What Sets You Apart (Preferred):
- Experience with other statistical software (e.g., R).
- Direct experience supporting NDA/BLA/MAA submissions.
- Knowledge of TA-specific standards (e.g., Oncology, Cardiovascular).
- Familiarity with UNIX and cloud-based computing environments.
Why Advance Your Programming Career at ICON?
1. Impact at the Core of Drug Development
- Your programming is the critical link between raw data and the statistical evidence used for regulatory decisions.
- Work on a diverse portfolio of studies across all phases and therapeutic areas.
2. Technical Leadership & Growth
- This role is a pathway to Lead Programmer, Principal Programmer, or Statistical Programming Manager positions.
- Access to ongoing training in advanced statistical methods, new technologies, and leadership skills.
3. Competitive Benefits & Collaborative Culture
- Highly competitive salary and performance-based bonus.
- Generous annual leave and flexible working arrangements.
- Comprehensive health, life, and retirement benefits.
- Global Employee Assistance Programme and a culture that values innovation, inclusion, and professional excellence.
Join a Team Where Data Drives Discovery
At ICON, we believe that diverse minds create the best solutions. We are committed to providing an inclusive, accessible environment and encourage all qualified programmers to apply.
Ready to code the future of medicine?
If you are a seasoned SAS programmer eager to apply your skills to meaningful clinical research, we want to hear from you. Apply now.
