Clinical Programming Manager
Essential Duties & Responsibilities:
1. Provides input for Budget Planning
2. Likely to oversee contingent workers and/or vendors; Likely to provide training to others
3. Primarily works at the project level
4. Delivers assignments with quality and within timelines
5. Contributes strategy under moderate supervision
6. Provides strong programming support to CDISC based e-submission. Develop, review, and/or perform validation of generic macros. Develop, debug, and enhance SAS programs to support quality control of safety or efficacy derived datasets
7. Has good knowledge and understanding of the statistical models in efficacy data analysis
8. Responsible for the standardization of Clinical Programming deliverables within a project
9. Extends existing or develops new clinical programming methods to solve complex problems
Education Required: Bachelor’s Degree/ Master’s Degree/ PhD in Science, Statistics, Information Technology or equivalent combination of education and related work experience. Experience Required: Bachelor’s + 5 years or Master’s + 4 years of professional experience in a pharmaceutical or clinical research setting as a programmer Experience Preferred:
Experience in SDTM and ADaM acquainted with CDISC Guidelines and requirements.
Specialized or Technical Knowledge Licenses, Certifications needed:
Functional Knowledge:
Advanced level of SAS programming skills. Develop SAS programs and perform QC tasks for integrated analysis. Company/Industry Related Knowledge: Intermediate knowledge of government regulations pertaining to drug development in multiple therapeutic areas. Job-Specific Competencies:
1. Contributes to strategy under moderate supervision
2. Tackles difficult problems; identifies solutions and recommends action to management
3. Influences communication toward common understanding and actionable results; contributes to process and development
4. Ability to effectively work in a global environment
5. Ability to effectively interact with and influence others without direct reporting relationships Pay ranges between $65-77.46/hr based on experience
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