Sr. Manager Clinical Programming

Key Features:

-Effectively designs and codes SAS programs for assigned project(s), consistently meeting objectives of the project
-Codes complex SAS programs for applications designed to analyze and report complex clinical trial data and for electronic submissions of data with minimal instruction or input from supervisor
-Provides guidance on the resolution of highly complex clinical trial reporting problems within budget and time line constraints, while assuring high quality standards
-Performs quality control checks of advanced SAS code
-Responsible for maintaining excellent working knowledge of medical data, the design and phases of clinical trials, statistics, relevant regulatory requirements, and the pharmaceutical industry
-Make certain that documents and specification are consistent and comply with company standards by providing input into study protocol, CRF and data structures tables, listings and figures for phase I-IV clinical trials and submission activities
-Maintain records for all assigned projects and archiving of trial/project analysis and associated documentation
-Participate in the selection of CROs and supervise the trial activities of the CROs
-Provide input on process improvement initiatives and participate in non-clinical project activities
-Manages project timelines and schedules of specific phases of projects and contracts with internal personnel and outside customer representatives
-Other projects as assigned

Qualifications:

-B.S. in a math or science related field
-Minimum of five (5) years of relevant experience w/SAS in the pharmaceutical industry. Oncology experience preferred.
-Proven record of effective and successful project management tasks and skills
-Good understanding of global clinical trials practices, procedures, methodologies
-Demonstrates advanced experience with all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH
-Demonstrates advanced knowledge of electronic submissions and CDlSC
-Displays highly advanced knowledge regarding software validation and system development life cycle concepts
-Communicates effectively in verbal presentations and written technical reports to both internal and external customers

To find out more about Real please visit www.realstaffing.com