Clinical and Statistical Data Programmer

Role Summary

Clinical and Statistical Data Programmer — responsible for transforming clinical study data into clear, accurate tables, listings, and figures (TLFs) for publications, study reports, and regulatory submissions in an animal-health setting. Works with statisticians and data managers in a non-CDISC environment using internal specifications. Location: May consider remote.

Responsibilities

• Program & QC TLFs for clinical study reports and manuscripts using SAS (Base/Macro/ODS) and/or R; support requests for data listings, summaries, analyses or data visualizations under supervision of project statisticians.
• Build analysis and/or submission datasets (per protocol and internal specs) under the supervision of statisticians and data managers as per applicable regulatory requirements.
• Collaborate with data management and statistics on data review and validation to ensure clean and analysis-ready datasets.
• Automate & standardize: develop reusable macros/templates to create TLFs from upstream statistical analysis outputs; contribute to internal programming standards suited to animal health (non-SDTM/ADaM).
• Maintain rigorous quality and documentation practices for programming.
• Follow internal SOPs and GxP expectations for Animal Health.

Qualifications

• Required: Education: Bachelor's or Master's in Statistics/Biostatistics, Applied Mathematics, Data Science, Computer Science, or a quantitative life-science field.
• Required: Experience: 0-3 years in pharma/biotech, animal health, CRO, or related research environment.
• Required: Experience with SAS programming (data steps, PROC SQL, PROC REPORT/TABULATE, ODS Graphics, Macro, PROC SGPLOT/SGPANEL, graph template language).
• Required: Familiarity with data manipulation, reporting, and visualization R and/or Python.
• Required: Data mindset: comfort with messy real-world data; eagerness to learn animal-health study nuances.
• Required: Collaboration: clear written and verbal communication; ability to translate statistical and reporting requirements into programming specs with clear timelines.
• Required: Desire and aptitude to learn and grow in different programming tools to accomplish reporting and visualization tasks.
• Required: Creativity in reporting and visualizing data and information for clear interpretation.
• Preferred: 3-5 years' experience in pharmaceutical/animal health R&D in a clinical data management or statistical programming specialty and/or work in regulated environments.
• Preferred: Experience with graphics and reporting workflows (SAS ODS, R Markdown/Quarto, LaTeX) for submission/publishing.
• Preferred: Statistics foundation: experimental design, hypothesis testing, ANOVA, linear/mixed models.
• Preferred: Familiarity with VICH GCP, GLP, 21 CFR Part 11/Annex 11, and preparation of electronic data for regulatory submissions.
• Preferred: Experience with EDC/CDMS platforms (e.g., Medrio, Prelude); exposure to controlled terminology/standards (libraries, code lists, medical/veterinary dictionaries as applicable).
• Preferred: Knowledge of SAS for TLFs/listings or R/Python for data wrangling/automation; experience with Git (version control).
• Preferred: Experience with Basic Dashboarding skills - e.g., Power BI/Tableau/R Shiny (or similar).
• Preferred: Prior contribution to SOPs, templates, study libraries, and process improvement initiatives; experience mentoring junior staff.