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Senior Statistical Programmer
HistoSonics, Inc.. Contribute to development of the statistical analysis plan (SAP), proposing analysis approaches in collaboration with the clinical data scientist .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates advanced proficiency in statistical programming using SAS, with a strong understanding of TLF structure and clinical study data. Ensures adherence to clinical data standards such as CDISC, SDTM, and ADaM while maintaining high-quality programming standards and documentation.
Highest-signal resume keywords
Statistical Programming (SAS)Clinical Data Standards (CDISC, SDTM, ADaM)TLF Specification DevelopmentQuality Control and ValidationRegulatory Submissions Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Statistical ProgrammingData AnalysisTLF DevelopmentComplex Analysis DatasetsStatistical MethodsProgramming StandardsData VisualizationSAS ProgrammingR ProgrammingDocumentation
Soft Skills
Attention to DetailIndependent WorkCross-Functional CollaborationCommunication SkillsQuality-Control Mindset
Tools & Technologies
SASRTableauSpotfireR ShinyPython Dash
Industry Keywords
Clinical ResearchClinical TrialsMedical DevicePharmaceuticalRegulatory GuidelinesFDA StandardsISO 14155ICH Guidelines
Tech Stack
Tools & technologiesPythonTableau
About the role
Key responsibilities & impact- Contribute to development of the statistical analysis plan (SAP), proposing analysis approaches in collaboration with the clinical data scientist
- Independently define, develop, and validate tables, listings, and figures (TLF) specifications and shells
- Write, maintain, and review primarily SAS programs to generate analysis datasets and TLFs, including complex or non-standard outputs
- Execute programs and independently troubleshoot and resolve programming and data issues
- Incorporate TLF outputs into clinical study reports (CSRs) and other downstream deliverables
- Lead quality control and validation of programmed outputs, including independent/double programming and review of other programmers’ work
- Interpret analysis outputs and identify results warranting further statistical attention
- Ensure traceability, reproducibility, and adherence to relevant data standards, including CDISC, SDTM, and ADaM
- Maintain and improve programming standards, documentation, reusable code, and macros
- Partner with Data Management teams on dataset structure and specifications
- Assist Regulatory Affairs and Quality Assurance teams with programming deliverables for reporting and submissions
- Assist with additional analysis or clinical data science tasks as assigned
Requirements
What you’ll need- 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), including complex analysis datasets and TLFs
- 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
- 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)
Benefits
Comp & perks- Health, dental, and vision insurance
- Life insurance
- Short-term and long-term disability insurance
- 401(k)
- Paid time off