Description |
Specific Responsibilities: THIS IS NOT A STATISTICAL POSITION.
This position will work with other clinical programmers and interact with data managers to assist on multiple projects. Key duties include review of programming specifications, edit checks and listings, processing of lab data or PK data, and ad hoc programming. The ideal candidate will possess 1-2 years clinical programming experience within the pharmaceutical industry.
Essential Duties and Job Functions: Works collaboratively within Biometrics assisting in providing support to Clinical Data Management activities. Works with lead Clinical Programmer to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting. Ensures completeness, correctness and consistency of basic clinical data and data structure. Provides timely support to the study team on all programming matters according to the project plan and programming specification using well-defined internal standards and guidelines. Provides input to CRF/eCRF reviews and edits checks Contributes to the reporting of basic clinical data. Supports through regulatory approval, product launch and annual reports; contributing to the monitoring of data quality during study conduct.
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Requirements |
Knowledge, Experience and Skills:
Typically requires a BS degree in a Biomedical Science or equivalent and minimum 2 years of relevant experience along with clinical background/experience and SAS programming in a CRO or bio/ pharmaceutical setting, or a MS degree and minimum 1 year of relevant experience.
Excellent verbal and written communication skills and interpersonal skills are required. Knowledge of pharmaceutical clinical development and ability to provide programming supports needs for NDA and other regulatory submissions. Understanding of statistical concepts and techniques and of clinical trial principles is required.
When applying, please specify "LatPro.com - position title" at the top of your resume.
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