Sr Statistical Programmer I
About the role
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- Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance.
- As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
- Travel (approximately 5%) domestic and/or international
- Act as study lead for a project to coordinate all study activities and provide input to project documentation as appropriate including review statistical analysis plans and CRF's.
- Ensure projects are conducted in accordance with internal SOPs, client requirements, and Good Clinical Practices (GCP).
- *Carry out quality control checks to ensure compliance with Company and Sponsor requirements.
- Ensure accuracy of all results and ensure appropriate documentation.
- Prepare graphs, tables and listings for inclusion in clinical study reports.
- Write/follow appropriate SOPs and WPS for programming activities.
- Provide mentorship and training for other programmers.
- *Provide support to the Principal Statistical Programmer and Manager, Statistical Programming.
- *Ensure compliance with all training requirements.
- *Provide data transfers to company or sponsor standards.
- Attend and present at external meetings as appropriate.
- Under supervision perform senior review of complete programming deliverables.
- Participate in client audits where appropriate.
- Liaise with Data Management, QA, PK, Medical Writing, Stats and PM.
- Any other duties as assigned commensurate with skills and qualifications and appropriate to the role
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Educational Requirements
- Bachelor's degree, in a quantitative or scientific discipline, or local equivalent
- Substantial experience in SAS Programming, or equivalent, preferably in the Clinical Domain.
- Proven ability to produce report quality tables graphs and data listings without direct supervision
- Proven ability to drive process improvements within area of expertise
- Awareness of regulatory requirements and industry practice
- Expert knowledge of CDISC SDTM and ADAM requirements for submission is a must
- Advanced problem solving skills, attention to detail, good verbal and written
- Excellent communications skills
- Ability to transfer own knowledge to others and help them improve
Application process
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