Senior Statistical Programmer

KEY TASKS RESPONSIBILITIES

• Develop specifications for SDTM datasets and SDTM datasets specifications for Clinical Data Analysis.
• Develop SAS programming to produce SDTM datasets and SDTM datasets.
• Develop specifications for Analysis Data Model (ADaM) datasets.
• Develop SAS programming and validation of ADaM datasets for trial level reporting and integrated safety and efficacy activities.
• Responsible for developing and maintaining programming and validation specifications for TLGs as per requirements provided by the Biostatistician.
• Create and maintain SAS programs to produce outputs to support the analysis and reporting of clinical trials.
• Program and QC data listings, summaries and Graphs as defined in SAP. If required, validate the statistical models used for programming.
• Develop re-usable utility macros to build a macro library to support programming tables, listing and graphs for phase 1-4 clinical trial reporting.
• Collaborate with the project team to ensure the deliverables are completed on time and with high quality.
• Create submission-ready standard data presentations and data sets using standard coding and following standard industry processes including SDLC.
• Maintain all project documentation as required by SOP and Processes
• Mentor statistical programmers
• Ensure compliance with eClinical Solutions and industry quality standards, guidelines, and procedures.
• Other duties as assigned.

Education / Language :

Technical Skills Experience

Skills Required

Proc Sql, Sas, Sas Stat, Ods, Pharmaceutical, statistical programming