Description
Main duties/responsibilities:- Providing statistical programming and validation support for clinical study reports, overseeing programming activities by external vendors (e.g., CROs).
- Achieve timely progress in the following areas: analysis datasets, statistical tables, figures, listings, Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE), electronic submissions and other internal and external requests (e.g., publications)
- Developing and maintaining SOPs, SWPs and other related technical documents, providing input to the Database and CRF Development, creating edit check programs and providing feedback to the Data Management.
- Providing input in developing statistical analysis plans, specifications of analysis datasets, validation plans, and other related documents. Determining and researching SAS software upgrades and related systems and addressing maintenance issues.
Managing and developing team, maintaining standards for programming activities, and guiding/coaching Statistical programmers.
Qualifications and education required:
- Minimum of Bachelor's degree in Statistics, Computer Science, Mathematics, or a related science discipline. Masters preferred.
- Minimum 5 years experience in SAS programming for phase I-IV clinical trials in a pharmaceutical/CRO environment. 7+ years experience preferred.
- Some project experience in a pharmaceutical/CRO programming environment or demonstrated significant leadership of SAS programming activities in a clinical pharmaceutical/CRO environment.
- Experience using SAS-Base, MACRO, STAT, GRAPH, ACCESS, MS Office.
- Understanding of the software development life cycle.
To find out more about Real please visit www.realstaffing.com