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.

• Oversee multiple Statistical Programming teams in the creation, validation, and generation of 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 the statistical methods to be applied to clinical data.

• Conduct quality control and validation of statistical outputs to ensure accuracy, consistency, and compliance with regulatory standards.

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

• Identify opportunities for improving programming practices, automation, and R-based analytical workflows.

• Support the development, maintenance, and enhancement 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 field.

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

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

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

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

• Exceptional analytical and problem-solving abilities, with meticulous attention to detail.

• Strong communication skills, enabling effective collaboration within a team environment and the ability to articulate complex information clearly.

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

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

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

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