Principal SAS Programmer

TITLE: Principal Statistical Programmer (Contractor) REPORTING RELATIONSHIP: Director, Statistical Programming SCOPE: If you want to have an impact on the lives of patients with cancer, take a look at Client. With our diverse pipeline, passionate team, and extensive resources, we offer abundant opportunities to contribute to the transformation of cancer care. We know that every team member, regardless of their role, plays a critical part in advancing research and making a difference in the lives of patients with cancer. KEY RESPONSIBILITIES: Lead on clinical studies and integrated analyses and provide guidance and training to other lower level personnel. Develop or evaluate software tools, SAS macros, utilities to automate programming activities and support Biometrics team collaboration. Contribute and implement statistical analysis plans; provide additional expertise in the analysis of clinical trials when it relates to protocol development, case report form design, and data collection. Review Data Management Plan, Data Transfer Plan, Data Validation Plan, and Edit Check Specifications and provide comments. Work closely with Biostatistics to create analysis specifications following the instructions provided in Statistical Analysis Plan (SAP). Create CDISC SDTM and ADaM files, SAS export files, Define.xml, and Reviewer's Guide for Electronic Submission. Perform data analysis, statistical analysis, generate safety and efficacy tables, listings, and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL, and SAS/ODS. Interact with Statisticians and other clinical teams, perform ad hoc analysis and generate outputs according to the requirements. Help identify issues and initiate resolution of the problems. Act as a liaison between statistical programming, subcommittees, and project teams as needed. May serve as external spokesperson for the organization. Create/acquire tools to improve programming efficiency or quality control. Stay current with industry trends, best practices and improve statistical programming methodology. Other duties as assigned. PROFESSIONAL EXPERIENCE / QUALIFICATIONS: Minimum 10 years Pharmaceutical/Biotech programming experience including macro/tools development experience. FDA submission experience is highly desirable. Strong SAS programming and Statistical background with strong skills in SAS Base, SAS/Macros, SAS/Graph, and SAS/Stat. Ability to use professional concepts to achieve objectives in creative and effective ways. Experienced in managing multiple projects. Solid knowledge of SAS Programming language, Software Development Life Cycle, and CDISC standards (SDTM & ADaM). Solid knowledge of other software such as R is a plus. BS/MS in Statistics, Math or Scientific Discipline. Skills: Required: PHARMACEUTICAL/BIOTECH, SAS, STATISTICS, BIOMETRICS Additional: STATISTICAL PROGRAMMING FORM DESIGN MARKETING ANALYSIS STATISTICAL ANALYSIS ODS CASE REPORT QUALITY CONTROL DATA VALIDATION BIOSTATISTICS LIAISON CLINICAL TRIALS DATA MANAGEMENT OPERATIONAL DATA STORE SQL XML DATA ANALYSIS COLLECTION FDA AD HOC ANALYSIS SAP, CLINICAL STUDIES

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