Maintain the highest level of professionalism, productivity, and quality of assigned projects
Manage or assist project assignments and programming team as assigned.
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.
Timely completion of client specific and organization specific training documentation
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, Skill & Experience:
Any bachelor or masters degree, preferably in Computer Science, Engineering, Mathematics, Statistics or Life Sciences
Minimum 5-7 years of relevant SAS programming experience for any clinical trial phases and demonstrate the ability to independently perform SAS programming.
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.