Principal Statistical Programmer

This is a fully remote position, open to applicants in Romania, +5 more countries.

📋 Description

• Design and validate R programs for the statistical analysis and reporting of clinical trial data.

• Supervise multiple Statistical Programming teams to develop, validate, and produce statistical outputs, such as listings, tables, figures, and CDISC-compliant SDTM and ADaM datasets, including mapping specifications, of low to moderate complexity.

• Collaborate with biostatisticians to establish analysis plans and statistical methods used in clinical data.

• Conduct quality control and validation of statistical outputs to ensure precision, consistency, and adherence to regulatory standards.

• Aid in the preparation of statistical reports, presentations, and publications for regulatory submissions and clinical study documentation.

• Contribute to enhancements in processes by identifying efficiencies in programming practices, automation, and R-based analytical workflows.

• Assist in the development, maintenance, and improvement of standardized R programming tools, macros, and reporting solutions across various studies.

⛳️ Requirements

• Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related quantitative discipline.

• Over 8 years of experience in statistical programming within clinical research, biotechnology, or pharmaceutical sectors.

• Extensive experience in leading programming efforts for clinical studies.

• Advanced proficiency in R programming, including the creation and validation of clinical trial datasets, analyses, and reporting outputs.

• Solid understanding of CDISC standards, specifically SDTM and ADaM, and their implementation in clinical trials.

• Familiarity with regulatory requirements and industry guidelines concerning statistical programming and clinical data reporting.

• Exceptional analytical and problem-solving abilities, with a strong focus on detail.

• Excellent communication skills, capable of working collaboratively in a team setting and effectively conveying complex information.

• Employment with ICON is contingent upon possessing the legal right to work in the country where the role is based.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellbeing programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Opportunities for learning and development through structured training and career pathways.