
Data Science and Analysis Expert
4 days ago
Job Overview
The Senior Statistical Programmer will be responsible for providing programming support for clinical trials.
Key Responsibilities:- Exceed the responsibilities of a Statistical Programmer II.
- Implement regulatory standards such as CDISC and others.
- Follow internal SAS programming conventions.
- Lead on assigned studies as the programming lead.
- Coordinate and ensure accuracy and completeness of activities for assigned support programmers.
- Develop project timelines.
- Support the development of tools and macros to improve quality and efficiency of processes.
- Prepare programming specifications for SDTM, ADaM, and other derived datasets.
- Apply knowledge of SAS programming to program/develop and/or validate statistical outputs according to the statistical analysis plan and other specifications; including but not limited to:
- Analysis datasets (SDTM, ADaM, other derived datasets).
- Tables, listings, and figures.
- xml/Reviewer's Guide.
- Integrated summaries.
- Perform ad hoc analyses of current and legacy databases.
- Review and provide input on case report form design.
- Act as a mentor to other programmers.
- Maintain awareness of scope of work to actual work, alerting management of potential change orders or resourcing needs.
- Work effectively with other programmers, statisticians, data managers, database programmers, and other cross-functional team members to ensure accurate and high-quality statistical outputs.
Additional Responsibilities:
- May assist in the preparation and review of monthly financial reporting.
- May promote visibility outside of the functional area and effectively interact cross-functionally and in industry.
- May participate in candidate interviews.
- Perform other duties as requested by management.
- A degree in Statistics, Computer Science, or a closely related field; work experience may be substituted for degree.
- Minimum of 4 years direct SAS programming experience in pharmaceutical development or CRO environment.
- Good knowledge of medical terminology and conduct and analysis of clinical trials.
- Knowledge of relevant industry data standards (e.g., CDISC SDTM, ADaM, etc.).
- Excellent oral and written communication skills, organizational skills, and attention to detail are required.
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