Description
New Contract Opportunity!!CRO in Cambridge MA
6 months contract to hire.
Statistical Programmer
The Statistical Programmer/Senior Statistical Programmer will provide specialized knowledge and support to carry out statistical programming activities in support of multiple phase 1 through 4 clinical trials in varied indication areas.
RESPONSIBILITIES:
*Develop SAS programs to produce statistical tables, graphical representations, and data listings for individual study reports in accordance with the Statistical Analysis Plan (SAP).
*Develop SAS programs to produce integrated analyses and tables for the summary sections of New Drug Applications (NDAs) including ISS and ISE.
*Develop specifications (metadata files) and create SAS programs for the mapping of raw datasets to CDISC SDTM standards. Create define.xml files from metadata files and blankcrf.pdf using Adobe Acrobat.
*Develop SAS programs to produce analysis datasets in CDISC ADaM or other formats specified by the sponsor.
*Design and implement quality control (QC) programs to ensure the quality and integrity of statistical programs which are used to generate datasets including CDISC SDTM and ADaM datasets.
*Perform validation programming to ensure accuracy of summary tables and compliance with SAP and FDA regulatory requirements. Perform QC on program code and outputs produced by other team members.
*Participate in the development of a library of SAS macros for use across multiple projects and in training biostatisticians and other programmers in their implementation.
*Assist the Data Management Department by writing and testing edit check programs to check the data for syntax errors, logical inconsistencies, and protocol violations, and generate data listings to facilitate data review performed by the clinical data managers.
*Provide input to the study team in the design of annotated case report forms in conjunction with the clinical data managers.
*Perform other duties as assigned.
REQUISITE SKILLS:
*Experience with SAS® for Windows, including BASE SAS (macros, ODS, SQL), SAS/ACCESS, SAS/STAT, SAS/GRAPH
*Skilled at writing complex SAS programs designed to analyze and report clinical trial data and transform data to CDISC SDTM and ADaM formats
*Understanding of Code of Federal Regulations (CFR) Title 21, Part 11 that covers the management of electronic records and electronic signatures in computer systems
*Proficient in written communication and ability to communicate effectively to other programmers and non-technical colleagues
EDUCATION/EXPERIENCE:
Must have a bachelor's degree in Computer Science, Mathematics, Statistics, Life Sciences or a related field with at least 2 years of experience using SAS in analyses of clinical trials data. Prior experience in CDISC programming is a must. Knowledge of other programming languages and database management software packages is a plus. Title and compensation will be commensurate with experience.
Please send me an updates resumes ASAP.
Thanks
Paul
To find out more about Real please visit www.realstaffing.com