USITSP - Statistical Programmer

Job Title: Statistical Programmer

Reports to: Head, Statistical Programming

Job Purpose

Responsible for statistical programming of deliverables for assigned studies or project-level activities under the guidance of a Trial Programmer.

Key Responsibilities

• Develop primary programs to generate outputs in accordance with TFL shells, programming instructions, and dataset specifications.
• Validate statistical deliverables.
• Create study, project, or global macros to streamline processes.
• Contribute to the development and review of dataset specifications.
• Ensure timely and high-quality delivery of assigned tasks.
• Manage multiple tasks to meet project timelines.
• Identify and resolve programming issues; escalate when necessary.
• Communicate deliverable status and risks to Trial Programmer and supervisor.
• Support development of standards, processes, and knowledge sharing within the programming team.

Key Performance Indicators

• Quality and timeliness of deliverables.
• Compliance with regulatory and internal standards.
• Effectiveness of task management and communication with team members.

Impact on Organization

• Timely, high-quality programming outputs support product submissions and development, reducing potential delays or financial impact.
• Ensure the organization's quality reputation with regulatory bodies.

Required Competencies

• Proficient SAS programming skills, including macro development.
• Understanding of statistical concepts.
• Knowledge of regulatory guidelines (e.g., GCP, ICH) and industry standards (e.g., CDISC).
• Strong written and verbal communication skills.
• Ability to collaborate globally and manage tasks effectively.

Language

• Proficiency in English (reading, writing, speaking).

Education

• Bachelor’s, Master’s, or equivalent degree in mathematics, statistics, computer science, health sciences, or a related field.

Minimum Requirements

• At least 2 years of relevant programming experience.

Preferred Requirements

• Experience in the pharmaceutical or medical device industry.