- Assist in developing and maintaining statistical analysis programs to support clinical data for Phase I – III clinical trials and drug development projects
- Analyze and evaluate clinical data, identify inconsistencies and initiate resolution of data problems
- Implement the programming for statistical analysis plans and final clinical study reports
- Independently perform SAS programming and provide support for statistical analyses
- Produce and implement SAS programs for standard and custom data listings, tables, and figures for inclusion in clinical study reports and FDA submissions
- Test, document, review and validate all programs according to specified guidelines
- Develop, document, and execute SAS programs for such tasks as: creating datasets for analysis; producing data listings, summary tables and graphics for interim and final analyses and publications; and performing ad-hoc analyses.
- Contribute to the evaluation, development, design, implementation and maintenance of a biostatistical computing strategy, including a standardized SAS database structure that meets the specifications of the FDA and other regulatory agencies and standardized SAS macros.
- Manage documentation and validation activities surrounding statistical programming, writing work instructions for using programs or macros, monitoring change control aspects of validated programs, and training users on these programs or macros.
- Review study materials for conformance with standardized data base structure and standardized statistical programs and assist in regulatory oversight activities.
SKILLS AND EXPERIENCE:
- Experience with SAS data files for statistical analyses which may include importing data and converting data to SAS files; ability to integrate data within studies and across projects
- Knowledge of statistical standards and specifications following internal and regulatory guidelines
MINIMUM EDUCATION: Minimum of a Bachelor’s degree with more than 10 years of directly related experience.