The purpose of this position is to provide study level statistical programming expertise by:

• Designing and executing analysis deliverables to meet the requirements of clinical studies.
• Managing and enforcing standards for derived datasets and analysis outputs to maximize global data Integrability.
• Directing the work of offshore statistical programming team to achieve quality and timely study deliverables.

Responsibilities, Challenges, Expectations and Deliverables for this position:

• Represent the statistical programming function in support of assigned clinical studies.
• Independently develop, execute, and maintain SAS computer programs, including macro programs, according to Statistical Analysis Plans (SAPs), cross-study analysis and data specifications
• Produce statistical analysis output (tables, listings and graphs) to support generation of critical (flash) clinical study results, cross-study results for investigator brochures, regulatory submissions, or ad-hoc and exploratory analyses involving descriptive and simple inferential statistics.
• Perform data manipulations, including creation of derived data sets, related to the production of the statistical output.
• Verify (QC) study and cross-study analysis results or derived data sets produced by another statistical programmer, statistician, or an external vendor.
• BS in Statistics, Computer Science, or other related field with minimum 6 years SAS programming experience in the pharmaceutical/CRO industry; or MS in Computer Science, Statistics, or other related field with minimum 5 years SAS programming experience in the pharmaceutical/CRO industry.
• Advanced knowledge of SAS programming language and Base SAS, SAS/GRAPH parts of SAS software, good knowledge of common procedures in SAS/STAT.
• Good knowledge of general programming and computing principles, experience with Windows NT and UNIX operating systems, and common software products and technologies used in conjunction with SAS, expertise in office software (Microsoft Office).
• Good understanding of clinical study documents (protocol, CRF, SAP, Clinical Study Report).
• Working knowledge of clinical study designs, common analysis methods, descriptive and simple inferential statistics, and data