This hybrid role as a subject matter expert in biostatistics and statistical programming focuses on designing programming and validating clinical study analyses using SAS and Base SAS. The skilled will support global teams by transforming complex clinical and observational data into reliable statistical outputs that drive regulatory submissions healthcare decisions and innovative therapies ensuring high quality and compliance in every deliverable.
Responsibilities
Transform complex clinical trial and observational datasets into well structured analysis datasets using SAS and Base SAS to enable robust statistical evaluation of study outcomes.
Develop maintain and optimize reusable SAS programs and macros that streamline recurring statistical programming tasks and improve efficiency across multiple clinical projects.
Create accurate tables listings and figures from clinical data using SAS procedures and data step programming to support study reports and regulatory documentation.
Validate programming outputs through independent code review and rigorous comparison against specifications to ensure consistency traceability and regulatory grade quality.
Collaborate closely with biostatistics and data management teams to interpret statistical analysis plans and translate them into detailed programming specifications and execution steps.
Apply biostatistical principles to implement standard and advanced analyses that address efficacy safety and exploratory endpoints in clinical and post marketing studies.
Conduct thorough discrepancy investigation and data driven issue resolution for programmed outputs by analyzing logs datasets and results to maintain data integrity.
Document all programming activities including dataset derivations logic decisions and validation evidence in a clear and audit ready manner aligned with company and regulatory standards.
Contribute to continuous process improvement by proposing refinements to programming workflows standard c