Statistical Programmer II

This is a fully remote position, open to applicants in North Carolina, +1 more state.

📋 Description

• Assist in programming tasks for various projects related to clinical study reports and publications.

• Responsible for delivering clinical statistical programming outputs while ensuring high standards of quality and adherence to timelines for clinical trials managed by the Statistics & Data Management team.

• Work collaboratively with Statistics, Data Management, Clinical, and vendor teams to clarify requirements and troubleshoot data or programming challenges.

• Create, validate, and sustain SAS programs in line with study specifications, internal standards, and SOPs.

• Contribute to the development, validation, and documentation of SDTM and ADaM datasets.

• Accountable for generating programming results, validation processes, and associated documentation to guarantee accuracy, consistency, and traceability.

• Ensure that deliverables align with expectations concerning timelines, quality, regulatory standards, and key user group requirements (e.g., CDISC), as well as operational efficiency and the clinical and statistical goals of the study.

• Provide insights into SAP, analysis specifications, and data presentations for clinical trials.

• Assist in ongoing workflow modernization, migration efforts, and standardization projects.

• Engage in process improvement initiatives related to programming efficiency, quality, and standardization.

⛳️ Requirements

• A Bachelor’s degree or higher in statistics, mathematics, computer science, life sciences, data science, or a related discipline.

• Relevant experience in clinical trial programming, clinical data analysis, statistical programming, or regulated data environments.

• Proficient SAS programming skills, including data steps, procedures, macros, and debugging techniques.

• Capability to write clear, validated, reusable, and well-documented code.

• Knowledge of programming quality control, validation, and traceability standards.

• Familiarity with CDISC standards, particularly SDTM and ADaM.

• Ability to assist in dataset creation, validation, listings, tables, figures, and ad hoc analyses.

• Comprehension of the clinical trial data flow from data collection to analysis/reporting.

• Strong attention to detail and commitment to quality.

• Capability to work independently on assigned tasks while receiving appropriate guidance.

• Effective communication skills and the ability to collaborate with Statistics, Data Management, Clinical, and external vendors.

• Skill in managing priorities and timelines in a dynamic project environment.

🏝️ Benefits

• Health benefits – Medical, Dental, Vision

• Personal and Vacation Time

• Retirement & Savings Plan (401K)

• Employee Stock Purchase Plan

• Training & Education Assistance

• Bonus

• Referral Program

• Service Awards

• Employee Recognition Program

• Flexible Work Schedules