Senior Statistical Programmer

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $100k - $115k / year

⏰ Full Time

🟠 Senior

🖥 Software Engineer

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HistoSonics, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2009

🏭 Manufacturing

🏥 Healthcare

🧬 Biotechnology

Manufacturing • Healthcare • Biotechnology

HistoSonics, Inc. is a pioneering medical technology company that has developed a non-invasive sonic beam therapy platform using a treatment called histotripsy. This innovative approach harnesses focused ultrasound to mechanically destroy targeted liver tumors at a sub-cellular level. HistoSonics is dedicated to advancing the science of histotripsy, aiming to provide transformative benefits for patients and physicians worldwide, particularly through its ongoing clinical trials and educational programs.

📋 Description

• Support analysis and reporting of complex clinical data across clinical trials, real-world evidence (RWE), and observational studies for medical devices • Generate tables, listings, and figures (TLFs) summarizing study results • Contribute to statistical analysis plan (SAP) development and propose analysis approaches with the clinical data scientist • Independently define, develop, and validate TLF specifications and shells • Write, maintain, and review primarily SAS programs to generate analysis datasets and TLFs • Execute programs and troubleshoot and resolve programming and data issues • Incorporate TLF outputs into clinical study reports (CSRs) and downstream deliverables • Lead quality control and validation of programmed outputs, including independent/double programming • Review other programmers’ work • Interpret analysis outputs and identify results requiring further statistical attention • Ensure traceability, reproducibility, and adherence to CDISC data standards, including 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

• 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

• Health insurance • Dental insurance • Vision insurance • Life insurance • Short-term disability insurance • Long-term disability insurance • 401(k) • Paid time off • Comprehensive benefits package for full-time employees • Equal opportunity employer valuing diversity