About the role

R-focused Statistical Programmer II supporting high‑visibility clinical trials for Parexel. Fully remote position requiring programming skills and knowledge of clinical research standards.

Responsibilities

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).

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.