Statistical Programmer II

Summary

Parexel is seeking a Statistical Programmer II to support clinical research projects through statistical programming and project coordination. The role involves producing and quality-controlling clinical datasets, tables, figures, and listings; maintaining regulatory documentation; supporting training; and ensuring compliance with applicable standards and regulations.

Responsibilities

• Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation
• Deliver best value and high quality service
• Check own work in an ongoing way to ensure first-time quality
• Use efficient programming techniques to produce derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures, and data listings
• Assist in the production/QC of derived dataset specifications and other process supporting documents and submission documentation
• Maintain and expand local and international regulatory knowledge within the clinical industry
• Develop knowledge of SAS and processes/procedures within other Parexel functional areas
• Provide relevant training and mentorship to staff and project teams as appropriate
• Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulator compliance
• Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required
• Proactively participate in process/quality improvement initiatives
• Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions)

Skills

• * Excellent analytical skills
• * Proficiency in SAS
• * Knowledge and understanding of the programming and reporting process
• * Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11
• * Ability to learn new systems and function in an evolving technical environment
• * Ability to manage competing priorities and flexibility to change
• * Attention to detail
• * Ability to successfully work as part of a global team
• * Work effectively in a quality-focused environment
• * Effective time management in order to meet daily metrics or team objectives
• * Show commitment to and perform consistently high quality work
• * Business/operational skills that include customer focus, commitment to quality management, and problem solving
• * Competent in written and oral English
• * Good communication skills
• * Educated to degree level in a relevant discipline and/or equivalent work experience

Qualifications

Must Haves

• * Excellent analytical skills
• * Proficiency in SAS
• * Knowledge and understanding of the programming and reporting process
• * Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11
• * Ability to learn new systems and function in an evolving technical environment
• * Ability to manage competing priorities and flexibility to change
• * Attention to detail
• * Ability to successfully work as part of a global team
• * Work effectively in a quality-focused environment
• * Effective time management in order to meet daily metrics or team objectives
• * Show commitment to and perform consistently high quality work
• * Business/operational skills that include customer focus, commitment to quality management, and problem solving
• * Competent in written and oral English
• * Good communication skills
• * Educated to degree level in a relevant discipline and/or equivalent work experience

Benefits

• Remote work arrangement