Senior Statistical Programmer
$100,000–$115,000 year
Remote
Job Summary
Develop tables, listings, and figures (TLFs) from complex clinical datasets for medical device trials, real-world evidence, and observational studies. Independently define, validate, and execute SAS programs to generate analysis outputs, while contributing to the statistical analysis plan (SAP) and incorporating results into clinical study reports. Lead quality control through independent programming reviews, troubleshoot data issues, and ensure adherence to CDISC standards. Partner with data management teams on dataset specifications and assist regulatory affairs with submission deliverables. Work remotely across the contiguous United States with 10-20% travel, reporting directly to the clinical data scientist within a cross-functional team.
Required Qualifications
- Bachelor's or Master's degree in a relevant technical field (e.g., statistics, computer science, mathematics, data science, or epidemiology)
- Minimum of 5 years of statistical programming experience in clinical research
- Advanced proficiency in statistical programming (SAS or R; SAS preferred)
- Familiarity with clinical data standards (CDISC, including SDTM and ADaM)
- Working knowledge of statistical methods used in clinical trials
- Strong understanding of TLF structure and clinical study data
- Ability to work independently and manage multiple deliverables and deadlines within a cross-functional team
- Strong attention to detail and a quality-control mindset, including review of others' work
- Good written and verbal communication skills
- 10-20% travel
Desired Qualifications
- Experience producing TLFs for clinical study reports or regulatory submissions
- Familiarity with regulatory guidelines and standards (FDA and Global; e.g., ISO 14155, ICH)
- Experience in medical device or pharmaceutical clinical trials
- Familiarity with data visualization tools (Tableau, Spotfire, R Shiny, Python Dash)
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