Principal Statistical Programmer

Provide lead statistical programming support in the project specific programming of CDISC datasets (SDTM, ADaM), analysis outputs (tables, listings, figures), and ad hoc reports of all complexities. Provide leadership in project management of trials across several therapeutic areas. Follow and provide input into company Standard Operating Procedures (SOPs) and process. Responsibilities: Responsible for coordinating and Leading programming of clinical data analyses. Analyzes and evaluates clinical data, recognizes inconsistencies, and initiates resolution of data problems. Typically, programs using SAS language to support the clinical area. Implements statistical analysis plans. May consult in the design and development of clinical trials, protocols, and case report forms. Validate work of other programmer(s) Ensure the maintenance of programming documentation (e.g., description of programs and validation) Interacts with statisticians, data management personnel, project leaders, and sponsors. Communicate to management on project status and resource issues. Investigate and propose initiatives for improving efficiency. Qualifications: Requires a bachelors degree, Masters degree preferred in a scientific discipline. Minimum 9 years of relevant work experience Thorough knowledge of computer systems, applications, and operating systems Strong analytical skills Ability to simplify complex issues into understandable concepts. Provide mentoring to junior staff statistical programmers. Skills: Strong written and verbal communication skills including good command of English language. Proficiency with various computer applications such as Word, Excel, and PowerPoint required Requires expert knowledge/experience of SAS/Base, especially macros, arrays, formats and ODS. Expert knowledge of SAS/STAT and SAS/GRAPH is also required. Requires familiarity with basic statistical principles to interact with biostatisticians. Requires excellent written skills and ability to interpret and implement table manuals and statistical analysis plans. Requires advanced knowledge of drug development principles related to the production of databases and summary tables, such as CDISC standards. Requires ability to write validation plans.