Provide statistical programming expertise and support to team members. Responsibilities include the following: 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 in CDlSC format 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 and output produced by other Statistical Programmers; responsible for maintaining excellent working knowledge of medical data, the design and phases of clinical trials, statistics, relevant regulatory requirements, and the pharmaceutical industry; identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications); may conduct briefings and participates in technical meetings for internal and external representatives (e.g., IS, CROs, Clinical Development Partners, Software Vendors, FDA, EMEA, et cetera), on assigned projects; oversees project timelines and schedules of specific phases of projects and contracts with internal personnel and outside customer representatives; and performs other duties as assigned.
Must have MS in statistics, biostatistics, or closely related major in the statistical field and 3 years of experience with statistical programming, SAS and data analysis. Experience must include providing statistical programming expertise in SAS for the production of analysis, tabulations, graphics and listings from clinical trial data; performing validation programming to ensure accuracy of TFLs and compliance with SAP and FDA; providing technical leadership on cross functional teams; and developing SAS macros. We will also accept BS and 5 years of experience.