Senior Statistical Programmer

• Prepare clinical and statistical reports using SAS
• Create tables, data listings, graphs and analysis to support medical and clinical review, and to enable the data-driven operation and decision in clinical trials
• As the owner of business intelligence, communicate with management and project teams for report requirements and specifications and standardize the basic reports in supporting the Risk-based Monitoring and solving operational or data problems for clinical trials
• Work with study statisticians to support abstracts, posters, manuscripts and other clinical publications
• Understand Clinical Data Interchange Standards Consortium (CDISC), Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) standards and regulatory requirements
• Work on oncology studies to perform safety and efficacy analysis
• Develop SAS macros, templates and utilities for data reporting and visualization
• Be able to write and validate SAS programs to generate tables, listings, and figures (TLFs) for clinical study reports (ICH E3 Clinical Study Reports ) and analysis datasets
• Follow best practice in programming documentation

Requirements:

• 7+ years of experience in statistical programming in biotech or pharmaceutical companies
• Minimum Bachelor's degree; Master's degree in statistic preferred, computer science with a particular focus in biostatistics considered
• Extensive experience analysing and interpreting clinical trial data
• Knowledge of Medidata Rave and Oracle Inform system and clinical database structure
• Experience in Phase I/II/III oncology clinical trials preferred
• Previous data visualization experience preferred
• Excellent communication skills