Senior Statistical Programmer

Responsibilities :

• Generating and validating statistical programming deliverables (SDTM, ADAM, TFL's) in Early Development Statistics and PK / PD Modeling and Simulation spanning all therapeutic areas.
• Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS / Client), utilizing SAS programming.
• Generating complex ad-hoc reports utilizing raw data.
• pplying strong understanding / experience of Efficacy analysis.
• Creating and reviewing submission documents and eCRTs.
• Communicating with and / or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries.
• Performing lead duties when called upon.
• Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
• Being adaptable and flexible when priorities change
• Develop and validate global programming standards for ADaM datasets.
• Develop and validate global programming standards for efficacy analysis, safety analysis and reporting.
• Design and develop complex programming algorithms.
• ssist project teams in creating SDTM deliverables for Analysis and Reporting (A&R) and submission.
• Support project teams in preparing submission deliverables including use of Pinnacle 21 Enterprise.

Requirements :