NavitsPartners
USITSP - Statistical Programmer
NavitsPartners, Denver, Colorado, United States, 80285
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.
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.