Senior Biostatistician

PaceMate™•Clearwater, FL

4d•$136,425 - $172,850•Remote

About The Position

The Senior Biostatistician is PaceMate’s first biostatistician and independently leads the statistical design, analysis, and reporting of clinical research, including internal quality and research studies and externally published work. The role owns studies from analysis planning through peer-reviewed publication and responses to reviewers, working directly with the Chief Medical Officer and clinical team. Approximately one quarter to one third of the role applies statistical methods to operational and business questions; routine operational reporting and dashboards are outside the role. AI-assisted tools are used daily, and the biostatistician is responsible for validating all results they help produce. The position offers latitude to shape its workflow and a potential path to expanded oversight of research-related functions. The role builds reusable research infrastructure with the data science team, maintains the analytic queue, and ensures published results can be reproduced from raw data extracts by script. It also provides statistical input and limited analyses for quality improvement, patient safety monitoring, and clinical operations as needed, but is not a primary QA role. Infrequent duties may include preparing IRB documentation and, when requested, evaluating predictive models. This is a remote position for candidates who reside and work exclusively within the contiguous United States. The employee must maintain a dedicated home office and reliable high-speed internet, and may need to travel to a limited extent based on business needs. The role reports to the Sr. Director of AI & BI or designee, with supervision at least quarterly, and has no supervisory responsibilities.

Requirements

PhD in biostatistics, statistics, or epidemiology; or a master’s degree in one of these fields with at least 8 years applying statistics to health data and clear independent ownership of analyses.
Lead or methods statistician experience on peer-reviewed cardiovascular clinical research in electrophysiology, heart failure, cardiac devices, or a closely related field; general healthcare analytics experience alone is insufficient.
Peer-reviewed publication track record as a contributing statistician, including successful responses to reviewer critique.
Command of methods for linked multi-table data; count and rate outcomes with exposure offsets; recurrent-event and time-to-event methods, including competing risks; clustered and repeated-measures data; confounding control in observational data; non-random missingness; and informative censoring.
High proficiency in R across the full analytic pipeline, including R Markdown or Quarto.
SQL skills sufficient to query and join relational clinical tables.
Reproducible practices, including Git, dependency management such as renv, scripted pipelines, and literate reporting.
Ability to explain methods and limitations to physicians and non-statistician managers, and willingness to state clearly when data cannot support a conclusion.
Current, regular use of AI coding assistants in analytical work, with a consistent method for checking output and protecting patient data.
Interest in applying statistical methods to operational and business questions.
Must reside and work exclusively within the contiguous United States and be legally eligible to work in the United States.
Must maintain a dedicated, separate home office or room and reliable, high-speed internet at the residence.
Must notify and receive approval from IT before working from a location other than the legal address on file.
Must comply with restrictions and security requirements regarding foreign transport of confidential information.
Must be able to remain stationary while working at a computer, operate a computer and other office equipment, communicate via voice and video, exchange accurate information using voice over internet protocol, and perform repetitive finger and forearm motions for data entry.

Nice To Haves

Research using CIED, electrophysiology, or remote monitoring data, especially transmission-level data.
Published work using target trial emulation.
Working knowledge of Python.
PStat or GStat certification is a plus.

Responsibilities

Write and execute statistical analysis plans for retrospective and real-world evidence studies, including target trial emulation; define estimands, cohorts, exposure windows, and outcomes with the Chief Medical Officer and clinical investigators.
Link and validate multi-table device data; confirm denominators, person-time, and follow-up; and address left truncation and immortal time bias around device implantation and remote monitoring enrollment.
Analyze count and rate outcomes, recurrent events, time-to-event outcomes with competing risks, and clustered data using appropriate statistical methods.
Control confounding with propensity score methods; handle informative censoring and missing data; and assess robustness using sensitivity analyses.
Write and review methods and results sections for abstracts and peer-reviewed manuscripts in accordance with STROBE and RECORD standards; respond to co-author and external advisor critique.
Respond to peer review through re-analyses, statistical sections of response letters, and defensible positions under methodological critique.
Evaluate operational and business changes using interrupted time series, segmented regression, difference-in-differences, and statistical process control; present effect estimates and confidence intervals to leadership in plain language.
Use AI coding assistants daily to write, review, debug, and document R and SQL code and analysis reports; validate all generated code and results and use only PaceMate-approved tools with protected health information.
Provide statistical input and limited analyses to support quality improvement, patient safety monitoring, and clinical operations when needed.
Build reusable research infrastructure with the data science team, including standardized cohort definitions, reusable R code, and templated outputs.
Maintain the analytic queue and documentation needed to reproduce each published result by script from the raw data extract.
Maintain a high-level understanding of PaceMate products and services; follow company policies, the Code of Conduct, and applicable mission, vision, and customer service standards.
Infrequently prepare IRB documentation, including determination requests and reliance materials.
When requested, evaluate predictive models for discrimination, calibration, clinical usefulness, and temporal and external validation.