There are 2 openings – one requires experience with PHASE 1 and the other one requires experience with PHASE II and III
1. Providing statistical programming and validation support for clinical study reports, overseeing programming activities by external vendors (e.g., CROs) when necessary and coordinating programming activities among the study programmers to achieve timely progress in the following
areas: SDTM datasets, ADaM datasets, statistical tables, figures, listings, and other internal and external requests. Accessing and converting data to SAS from Database management system and PC file formats (e.g., MS Excel, text files). Working with external vendors in order to develop or monitor the content and structure of SAS data sets.
2. Working closely with statistician, and other statistical programmers to generate and QC TLG outputs; review data specifications to ensure accuracy, quality and soundness of statistical programming algorithm; coordinate internal resource utilization to generate activities metrics for management review.
3. Providing input in developing specifications of analysis datasets, validation plans, and other related documents, reviewing data submission package including define file, and data reviewer’s guide documents.
4. Working independently to accomplish tasks and goals defined by supervisor and bringing in new ideas to improve the programming process.
• Minimum of Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related science discipline. Masters preferred.
• Minimum 6+ years of experience in SAS programming for phase I clinical trials in a pharmaceutical/CRO environment. FDA submission experience preferred.
• Some project experience in a pharmaceutical/CRO programming environment or demonstrated leadership in a clinical pharmaceutical/CRO environment.
• Submission experience a plus.
• Experience using SAS-Base, MACRO, STAT, GRAPH, ACCESS, MS Office.
• Experience in CDISC data standards, e.g. SDTM and ADaM
• Proven experience with Unix and Windows operating systems.
• Understanding of the software development life cycle.
• Understanding of FDA guidelines.
Source: Job Diva – Job Listing