Statistical Programmer II

LivaNova•Raleigh, NC

4d•$90,000 - $100,000

About The Position

As a global medtech company, LivaNova is driven by its Vision of changing the trajectory of lives for a new day and its Mission to create ingenious solutions that ignite patient turnarounds. The statistical programming team develops datasets from clinical trials and delivers tables, listings, and figures (TLFs) per Statistical Analysis Plans (SAPs) to support new products and therapies, as well as to generate evidence for marketed devices. This team also supports additional programming activities for clinical operations and other areas of the company, including R&D and Quality. The Statistical Programmer will support programming activities for multiple projects on clinical study reports and publications. This role is accountable for clinical statistical programming deliverables and for ensuring excellence in programming activities in terms of quality and timelines for clinical trials under the responsibility of Statistics & Data Management. The role involves collaborating with Statistics, Data Management, Clinical, and vendor teams to clarify requirements and resolve data or programming issues. The programmer will develop, validate, and maintain SAS programs in accordance with study requirements, internal standards, and SOPs, and contribute to the creation, validation, and documentation of SDTM and ADaM datasets. The role is responsible for producing programming outputs, validation, and related documentation to ensure accuracy, consistency, and traceability, ensuring deliverables meet expectations in terms of timelines and quality, regulatory and key user group requirements (e.g., CDISC), operational efficiency, and alignment with the study's clinical and statistical objectives. The role also provides input into SAP, analysis specifications, and data presentations for clinical trials, supports ongoing workflow modernization, migration activities, and standardization initiatives, and participates in process improvement activities related to programming efficiency, quality, and standardization.

Requirements

Bachelor’s degree or higher in statistics, mathematics, computer science, life sciences, data science, or related field.
Relevant experience in clinical trial programming, clinical data analysis, statistical programming, or regulated data environments.
Strong SAS programming skills, including data step, procedures, macros, and debugging.
Ability to write clear, validated, reusable, and well-documented code.
Understanding of programming quality control, validation, and traceability expectations.
Working knowledge of CDISC standards, especially SDTM and ADaM.
Ability to support dataset creation, validation, listings, tables, figures, and ad hoc analyses.
Understanding of clinical trial data flow from data collection to analysis/reporting.
Strong attention to detail and quality.
Ability to work independently on assigned tasks with appropriate guidance.
Good communication skills and ability to collaborate with Statistics, Data Management, Clinical, and external vendors.
Ability to manage priorities and timelines in a changing project environment.

Nice To Haves

Experience with R, Python, SQL, Git, or other modern programming/version control tools.
Experience with SAS Enterprise Guide or other SAS-based clinical programming environments.
Experience supporting medical device, neuromodulation, or cardiovascular/respiratory studies.
Familiarity with data visualization, dashboards, automation, or workflow improvement.
Experience working with vendors or cross-functional global teams.
Understanding of controlled programming environments, SOPs, and audit-ready documentation.

Responsibilities

Support programming activities for multiple projects on clinical study reports and publications.
Accountable for clinical statistical programming deliverables and for ensuring excellence in programming activities in terms of quality and timelines for clinical trials under the responsibility of Statistics & Data Management.
Collaborate with Statistics, Data Management, Clinical, and vendor teams to clarify requirements and resolve data or programming issues.
Develop, validate, and maintain SAS programs in accordance with study requirements, internal standards, and SOPs.
Contribute to the creation, validation, and documentation of SDTM and ADaM datasets.
Responsible for producing programming outputs, validation, and related documentation to ensure accuracy, consistency, and traceability.
Ensure deliverables meet expectations in terms of timelines and quality, regulatory and key user group requirements (e.g., CDISC), operational efficiency, and alignment with the study's clinical and statistical objectives.
Provide input into SAP, analysis specifications, and data presentations for clinical trials.
Support ongoing workflow modernization, migration activities, and standardization initiatives.
Participate in process improvement activities related to programming efficiency, quality, and standardization.