Principle Statistical Programmer

Responsibilities: • Provide quality deliverables by following corporate and departmental policies, procedures and applicable standards. • Perform data manipulation, analysis and reporting of clinical trial data. • Create analysis files, tables, listings, and figures and validation of those files. • Maintain project tracking and validation documentation. • Work well in an environment where team members may be distributed across multiple locations. • to ensure project objective alignment, clarity, accuracy and completeness of programming requirements. • Present statistical programming concepts to non-programming team members as necessary. • Collaborate effectively with cross-functional teams and interface with multiple stakeholders to manage timelines and priorities. • Serve as back-up to Principle Statistical Programmer as needed. Requirements: • 7-10+ years statistical programming experience with pharmaceutical/ CRO industry is required. • Strong Macro Development experience is required. • PK/PD Programming is a big plus. • Review planning documents (Statistical Analysis Plan, dataset specifications, etc.). • Required Qualifications BA/BSc or Master's in Statistics, Mathematics, Computer Science, Life Sciences or other related scientific subject with 7-8+ years of relevant experience. • Extensive regulatory submission and response experience. • In depth SAS Programming background with excellent analysis and reporting skills. • Command of drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials data. • Thorough knowledge of latest CDISC SDTM, ADaM and Define standards. • Ability to effectively oversee geographically diverse programming teams. • Project management or project planning experience on small to large scale drug development projects. • In depth knowledge of SAS Graph and Stat packages. Apply tot his job