Statistical Programmer II

Role Overview

• Assist in coordinating project start-up activities, including global program creation, tracking spreadsheets, and required documentation.
• Continuously check your own work to ensure first-time quality.
• Apply efficient programming techniques to produce derived datasets (e.g., SDTM, ADaM), tables, figures, and data listings of any complexity; perform QC for low–medium complexity datasets, tables, figures, and listings.
• Assist in producing and QC’ing derived dataset specifications, process-supporting documents, and submission documentation.
• Maintain and expand knowledge of both local and international regulatory requirements within clinical research.
• Build expertise in SAS and gain an understanding of processes within other Parexel functional areas.
• Provide relevant training and mentorship to colleagues and project teams.
• Maintain complete and accurate study documentation according to SOPs/Guidelines to ensure traceability and regulatory compliance.
• Ensure compliance with SOPs/Guidelines, ICH-GCP, and other applicable regulations (including 21 CFR Part 11); participate in internal/external audits and regulatory inspections as needed.
• Proactively contribute to process and quality improvement initiatives.
• Understand regulatory expectations related to industry technical standards (e.g., CDISC, 21 CFR Part 11, electronic submissions).

Requirements

• Bachelor’s degree in statistics, biostatistics, mathematics, computer science, or life sciences
• Excellent analytical skills
• Intermediate proficiency in the R programming language
• Knowledge of programming and reporting processes
• Understanding of SOPs/Guidelines, ICH-GCP, and applicable regulations such as 21 CFR Part 11
• Ability to learn new systems and work effectively in an evolving technical environment
• Strong ability to manage competing priorities and adapt to change
• Proven success working as part of a global team
• Effective time management to meet daily metrics and team objectives
• Business and operational skills including customer focus, commitment to quality, and problem-solving
• Strong understanding of CDISC standards
• Knowledge of statistical terminology, clinical tests, and protocol designs
• Excellent attention to detail with a commitment to quality
• Strong written and verbal English communication skills.

Tech Stack

• Google Cloud Platform

Benefits

• Exceptional long-term career security
• Opportunities to work with leading global biopharma and biotech organizations
• An extensive pipeline of impactful clinical research projects
• A supportive environment that values work–life balance and professional growth