Responsibilities:
- Support statistical programming activities for clinical trial data analysis.
- Develop SAS programs to create and validate analysis datasets (ADaM) and summaries (TFLs) for Clinical Study Reports and regulatory submissions (FDA, EMA, etc.).
- Collaborate with biostatisticians, project leads, and other stakeholders to ensure timely, high-quality deliverables.
- Develop and validate study and report programming using global CDISC, ICH, and Therapeutic Areas standards, following departmental SOPs and good programming practices.
- Maintain and manage a project plan, including resource forecasting; coordinate a global programming team; participate in departmental strategic initiative teams.
Requirements:
- Master’s degree (or equivalent) in Computer Science, Statistics, Applied Mathematics, Biomedical Engineering, or a related field + 3 years’ experience in the position or a related role; OR Bachelor’s degree (or equivalent) + 5 years’ experience.
- 3 years’ experience with all of the following:
- Developing analysis and reporting deliverables for Phase 2 and 3 clinical trials (analysis datasets, tables, graphics, listings) for planned and unplanned analyses.
- SAS programming in a clinical trial environment (data step/procedures, macros, graphics, ODS).
- Interpreting and executing clinical trial statistical analysis plans.
- Using CDISC standards to create ADaM and SDTM datasets.
- Designing/developing complex programming algorithms.
- Ensuring process compliance and deliverable quality.