Manager, Statistical Programmer

Job Description

KEY TASKS & RESPONSIBILITIES Determine resourcing needs per project load, deadline requirements and resource utilization Create or review and approve programming plans at study and project level Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Management Plans, SAPs, etc.) 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 Assist Biostatisticians by suggesting algorithms to address novel analysis requests Develop analysis datasets for trial level reporting and integrated safety and efficacy activities Program and QC data listings, summaries and Graphs as defined in SAP Develop re-usable utility macros to build a macro library to support programming tables, listing and graphs for all phases of clinical trial reporting Create submission ready SDTM and ADaM datasets following standard industry processes Performs peer review of all SAS Programmers deliverables Serve as Subject Matter Expert for Statistical deliverables and lead task forces to develop complex, technical solutions for projects or business needs Collaborate with the project team and other Professional Services Managers to ensure the deliverables are completed on time with high quality Develops and maintains good working relationships with internal cross functional teams and Clients Develops, revises, and maintains Standard Operating Procedures and Work Instructions. Assists in the training of Standard Operating Procedures and Work Instructions. Maintain all project documentation as required by SOP and Processes Ensure compliance with eClinical Solutions and industry quality standards, guidelines, and procedures May serve as Lead Statistical Programmer on projects when needed Other duties as assigned