Senior Biostatistician

About this role

• Locations (remote); candidates must reside in the United States **Position Scope:** The Senior Biostatistician is PaceMate's first biostatistician.
• The role independently leads the statistical design, analysis, and reporting of PaceMate's clinical research, including internal quality and research studies and externally published work.
• The role owns each study from analysis plan through peer-reviewed publication and response to reviewers, working directly with the Chief Medical Officer and PaceMate's clinical team.
• About a quarter to a third of the role applies the same methods to operational and business questions.
• Routine operational reporting and dashboards sit outside this role.
• AI-assisted tools are part of how this role works every day, and the role is accountable for validating every result they help produce.
• The position has latitude to shape its own workflow and a potential path to expanded oversight of research-related functions.
• **Essential Functions and Job Responsibilities:** * Write and execute statistical analysis plans for retrospective and real-world evidence studies, including target trial emulation.
• Define estimands (ICH E9(R1)), 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 implant and remote monitoring enrollment.
• * Analyze count and rate outcomes (Poisson and negative binomial regression with person-time offsets), recurrent events (Andersen-Gill, PWP, and frailty models; mean cumulative function), time-to-event outcomes with competing risks (cause-specific hazards, Fine-Gray, Aalen-Johansen), and clustered data (mixed-effects models, GEE).
• * Control confounding with propensity score methods (IPTW, overlap weights, matching).
• Handle informative censoring with IPCW and missing data with multiple imputation.
• Test robustness with E-values, negative control outcomes, and tipping-point analyses.
• * Write and review methods and results sections for abstracts and peer-reviewed manuscripts to STROBE and RECORD standards.
• Respond to co-author and external advisor critique.
• * Respond to peer review: 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 with confidence intervals to leadership in plain language.
• * Use AI coding assistants (e.g., GitHub Copilot, Claude, ChatGPT) daily to write, review, debug, and document R and SQL code and analysis reports.
• Validate all generated code and results before use, 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.
• This is not a primary QA role.
• * Build reusable research infrastructure with the data science team: standardized cohort definitions, reusable R code, and templated outputs.
• * Maintain the analytic queue and the documentation that lets any published result be reproduced by script from the raw data extract.
• * Maintain high level understanding of PaceMate products and services.
• * Maintain appropriate levels of current knowledge and the ability to interpret, comprehend, and apply policies.
• Assist in ensuring consistency in practices and PaceMate Mission, Vision, and Customer Service standards are met.
• Adhere to the Code of Conduct and all Company Policies and Procedures.
• **Non-Essential Functions:** * Infrequently, prepare IRB documentation, including determination requests and reliance materials.
• * When requested, evaluate predictive models for discrimination, calibration, and clinical usefulness (decision curve analysis), including temporal and external validation (TRIPOD+AI).
• **Qualifications:** An individual must be able to perform each Essential Function of the job satisfactorily.
• Reasonable accommodation may be provided to enable individuals with disabilities, who are otherwise qualified, to perform the essential functions.
• Nothing within this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.
• **Education and Experience:** * PhD in biostatistics, statistics, or epidemiology; or a Master's in one of these fields with at least 8 years applying statistics to health data with clear independent ownership of analyses.
• * Lead or methods statistician on peer-reviewed cardiovascular clinical research (electrophysiology, heart failure, cardiac devices, or closely related).

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