Lead Statistical Programmer - I

Location

India | India

Job description

Lead Statistical Programmer I 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) for complex studies.

Primary Responsibilities Include:

• Lead project assignments and programming team by acting as point of contact with the Project Management and sponsor team to ensure smooth coordination of the projects
• 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, programming for CDISC Data Standards (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.
• 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
• Forecast work for the team and provide a vision of the ongoing project objectives or milestones and provide clarity on the upcoming projects
• Assist in the development and maintenance of the SAS programs/macros, templates and utilities for data cleaning and reporting and to perform Reconciliation of the External data
• Provide advanced technical expertise and work under a minimal supervision to support various programming activities related to the clinical data analysis and reporting
• Provide mentorship for associates working on the project and support training requirements for the trainees or team members
• Provide inputs to improve the current processes and achieve efficiency and enable the processes are in line with the Regulatory/Industry requirements
• Perform a periodic evaluation of the Team members and provide feedback as and when required
• Support or assist in audit specific requirements for internal or external audits and contribute towards quality and process improvement initiatives
• 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 8-10 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