Senior Statistical Programmer

HISTOSONICS•Plymouth, MN

9h•Remote

About The Position

HistoSonics is a commercial-stage medtech company advancing the Edison® System, a novel non-invasive sonic beam therapy based on histotripsy. Since receiving FDA De Novo grant for the non-invasive destruction of liver tumors in 2023, the company has progressed beyond initial market entry into commercial expansion, reimbursement momentum, and ongoing clinical and pipeline development. In addition to its current liver tumor indication, HistoSonics is pursuing future indications across multiple applications including kidney, pancreas, prostate, neuro, women’s health, and other significant underserved human health areas, to realize the broader potential histotripsy across multiple disease states and medical specialties. We offer an exciting work culture where cutting-edge science meets real-world application, and each team member’s contribution is important to our success in ensuring our physicians and their patients get what they need most. The Senior Statistical Programmer supports the analysis and reporting of complex clinical data across clinical trials, real-world evidence (RWE), and observational studies for medical devices by generating the tables, listings, and figures (TLFs) that summarize study results. Working within a cross-functional team and directly with the clinical data scientist, the senior programmer independently develops, validates, and executes the programming that generates analysis outputs, contributes to the statistical analysis plan (SAP), provides feedback on the analysis results, and incorporates those outputs into clinical study reports (CSRs) and other downstream deliverables.

Requirements

Bachelor’s or Master’s degree in a relevant technical field (e.g., statistics, computer science, mathematics, data science, or epidemiology) and a 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, sufficient to contribute to analysis planning and to interpret outputs.
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.

Nice To Haves

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).

Responsibilities

Contribute to development of the SAP, proposing analysis approaches in collaboration with the clinical data scientist.
Independently define, develop, and validate TLF specifications and shells, working directly with the clinical data scientist.
Write, maintain, and review programs (primarily SAS) 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 CSRs and other downstream deliverables.
Lead quality control and validation of programmed outputs (e.g., independent/double programming), including review of other programmers’ work.
Interpret analysis outputs and identify results warranting further statistical attention from the clinical data scientist.
Ensure traceability, reproducibility, and adherence to relevant data standards (CDISC, including SDTM and ADaM).
Maintain and improve programming standards, documentation, and reusable code and macros.
Partner with Data Management teams on dataset structure and specifications.
Assist the Regulatory Affairs and Quality Assurance teams with programming deliverables for reporting and submissions as needed.
Assist with additional analysis or clinical data science tasks as assigned.