Senior Statistical Programmer II

Location

India | India

Job description

Senior Statistical Programmer II is responsible for producing and coordinating the SAS programs, output, study reports for clinical trial programs, independently perform quality control on the statistical outputs, and achieve First Time Right outputs. This position may function as study lead programmer on assigned projects and/or and act as subject matter expert (SME).

Primary Responsibilities Include:

• Maintain the highest level of professionalism, productivity, and quality of assigned projects
• Manage or lead project assignments and programming team for multiple and complex studies
• Maintain a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, Company Standard procedures and policies
• Actively participate in Project, kick off meeting, to understand the project scope, plan and timelines, and detailed project specific requirements
• Develop and/or validate specification for SDTM, ADaM, and Derived datasets
• Develop and/or validate programming for CDISC SDTM, ADaM, and derived datasets (Moderate-Complex)
• Develop and/or validate programming for integration of databases from multiple studies and sources.
• Develop and/or validate programming, and documentation of statistical programs for use in creating statistical tables, figures, and listings.
• Develop and/or validate the programming for utility and project specific macros.
• Create and/or review define packages [Define.xml], and reviewers guide [RGs] for CDSIC Data standards
• Maintain, verify and ensure the quality and accuracy of all assigned tasks to achieve First Time Right outputs
• Timely completion of client specific and organization specific training documentation
• Assist QA review
• Learn in progress and develop skill sets and competencies to perform the job role
• Provide mentorship to associates within statistical programming group
• Communicate to management on project status and resource issues
• Perform other duties as assigned by Department Head or Immediate Supervisor

Education:

• Any bachelor or master™s degree, preferably in computer science, engineering, mathematics, statistics or life science

Experience:

• Minimum 6-8 years of relevant SAS programming experience for all clinical trial phases and demonstrate the ability to independently perform SAS programming

Skills:

• Good working knowledge in all phases of clinical trials
• Exposure in working in various therapeutic areas
• Proficient in clinical industry standards, CDISC Data standards, ICH-GCP Regulatory guidelines, medical terminology and clinical trial methodologies
• Excellent verbal and written communication skills

Job tags

Salary