Job Title: Statistical Programmer
Employer: IQVIA
Location: Not specified
Salary: Not specified
Start Date: Not specified
Closing Date: Not specified
The Statistical Programmer is responsible for creating SAS programs to generate derived analysis datasets and content for tables, listings, and figures. This role involves providing programming support for project teams, ensuring alignment with development team objectives, and adhering to regulatory and quality standards.
Programming & Data Analysis:
Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures; ensure quality of analysis datasets and programming outputs through validation.
Project Support:
Provide programming support for project teams, including developing strategies, standards, specifications, and programmed analysis.
Submission Preparation:
Support the electronic submission preparation and review process.
Review Key Documents:
Review key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity of programming assumptions.
Vendor Interaction:
Interact with vendors regarding project standards, programming conventions, specifications, and file transfers.
Leadership & Quality:
Provide leadership to ensure quality deliverables by consistently applying standards and complying with regulatory requirements, SOPs, and departmental work practices.
Efficiency & Improvement:
Identify opportunities to increase efficiency and consistency within GBDS and vendor interactions. Support improvement initiatives.
Independent Work:
Lead and/or perform programming assignments with minimal supervision.
Education:
Bachelor’s degree in statistics, biostatistics, mathematics, computer science, or life sciences required.
Experience:
At least 3 years of programming experience in the industry. US military experience will be considered towards industry experience.
Skills:
Proficiency in SAS, R, or other programming languages to produce derived analysis datasets and TFLs.
Understanding of clinical data structure (e.g., CDISC standards) and relational databases.
Ability to handle and process upstream data (e.g., eDC, SDTM).
Ability to produce outputs to meet downstream requirements (e.g., ADaM, e-submission).
Familiarity with regulatory, industry, and technology standards.
Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs.
Ability to work in a team environment with clinical team members.
Experience:
Minimum of 3 years of clinical/statistical programming experience within pharmaceutical clinical development.
Knowledge:
Knowledge of the drug development process, clinical trial methodology, statistics, and familiarity with global regulatory requirements.
Additional Skills:
Experience with software packages (e.g., R) and the Linux operating system.
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. The company creates intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and global health.
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