Senior Statistical Programmer

Key Skills: Adam, SDTM Roles and Responsibilities: Lead statistical programming activities as Trial Programmer for assigned studies or project-level activities including requirements analysis, resource estimation, planning and tracking, development of programs and validation of deliverables Develop and review programming dataset specifications Coordinate activities of all programmers assigned to the same study or project. Conduct kickoff meeting to provide an overview of the study or project, discuss deliverables, roles and responsibilities, timelines, and conventions Remove barriers to facilitate quality, timely and efficient completion of deliverables. Ensure that programmers have all required inputs for their tasks Provide solutions to programming issues and/or ensure efficient implementation Build and maintain effective working relationships with relevant team functional representation. Effectively communicate the status of deliverables, changes to plan, risks and proposed mitigation strategy to relevant team, Project Programmer and supervisor Contribute to development of SP standards and processes, knowledge sharing and other tasks as assigned Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results Skills Required: Quality and timeliness of all deliverables for assigned studies or project-level activities Ability and effectiveness in leading activities and coordinating programmers assigned to the same study or project Adequate representation as Trial Programmer in the Clinical Trial Team. Effectiveness of communication and participation as assessed by the team members Compliance with internal and external standards as measured by audit findings Works effectively under minimal supervision of supervisor or Project Programmer who is responsible for the overall statistical programming strategy for the project Timely and high quality SP deliverables. Delays and errors in deliverables may impede submissions or other product developments and subsequent revenue loss to the company Efficient programming leading to quality submissions, and reduced time and costs for development and registration Ensuring external quality reputation of Company with Health Authorities Strong SAS programming skills including development and use of macros Extensive experience in requirements analysis, resource estimation, planning and tracking deliverables and coordinating activities Extensive experience in developing programming dataset specifications Good working knowledge of statistical concepts Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, ICH) and industry standards such as CDISC Excellent written and oral communication Ability to work well with others globally Minimum Requirements: 7 years of relevant experience in clinical Statistical programming & SDTM, ADaM, Analysis dataset and specification creation, (TLF)Table and Listing creation 2 years of proven ability to lead statistical programming activities as Trial Programmer Education: BA/BS/MS degree or equivalent experience in mathematics, statistics, computer science, health sciences or related field