USITSP - Statistical Programmer

4 days ago

Denver, United States NavitsPartners Full time
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.

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