Statistical Programmer

Required Skillsets:

• Proficiency in SAS / R programming languages for programming and validating ADaM datasets, TFLs, and statistical analyses.
• Expertise in statistical software and programming tools.
• Familiarity with clinical study protocols, Statistical Analysis Plans (SAPs), and Tables, Listings, and Figures (TLFs).
• In-depth understanding of statistical programming documentation.
• Knowledge of CDISC standards and familiarity with therapeutic areas such as Oncology, Immunology, and Neuroscience.
• Experience in generating TLFs, programming macros, and performing data manipulation using SAS.
• Experience with other statistical programming languages (R) is a plus.
• Strong ability to interact professionally with statisticians, study teams, and external partners.

Key Responsibilities:

• Collaborate with statisticians to develop, review, and approve Statistical Programming Plans (SPP).
• Implement Statistical Analysis Plans (SAP) and Statistical Programming Plans (SPP) to create ADaM data specifications.
• Develop and maintain programming documentation, including annotated program code, programming specifications, and validation plans.
• Perform quality control checks on statistical programming deliverables to ensure accuracy, consistency, and adherence to programming standards.
• Assist in the development and implementation of standard programming macros, utilities, and tools to improve efficiency and consistency in programming tasks.