Senior Biostatistician

Senior Biostatistician All U.S. 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). General healthcare analytics experience alone is not sufficient. Peer-reviewed publication track record as a contributing statistician, including successful responses to reviewer critique. Command of the methods this data demands: linking many related tables; 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 pipeline, including R Markdown or Quarto. SQL sufficient to query and join relational clinical tables. Reproducible practice by default: Git, dependency management (e.g., renv), scripted pipelines, and literate reporting. Ability to explain methods and limitations to physicians and to a manager who is not a statistician, and willingness to state clearly when the data cannot support a conclusion. Current, regular use of AI coding assistants in analytical work, with a consistent method for checking their output and protecting patient data. Interest in applying statistical methods to operational and business questions. Preferred: Research using CIED, electrophysiology, or remote monitoring data, especially transmission-level data. Published work using target trial emulation. Working knowledge of Python. Preferred or Required Certifications PStat or GStat a plus Physical Requirements: While performing the duties of this job, the employee will be consistently required to remain in a stationary position working at a computer, constantly operate a computer and other office equipment, and frequently communicate with customers and employees via voice and video. Must be able to exchange accurate information, with the ability to effectively utilize voice over internet protocol; and repetitive motions using fingers and forearms in data entry. Other Requirements: Home office setup: Maintain a dedicated, separate office or room at home to ensure privacy and professional working conditions. Connectivity: Maintain a reliable, high-speed internet connection at your residence. Geographic restriction: Must reside and work exclusively within the contiguous United States. Must legally be eligible to work in the United States. Notification protocol: You must inform and receive approval from the IT department before working from any location other than the legal address PaceMate has on file. To update your address or request approval for a temporary work location, contact PaceMate IT or your HR representative. Additional information is available in the PaceMate official handbook. Foreign transport of sensitive information: When confidential information is carried into a foreign country, it must be stored in an inaccessible form (e.g., encrypted external storage) or remain in the worker’s possession at all times. PaceMate workers may not take secret PaceMate information into another country without permission from Physical Security management. May require limited travel based on the needs of the business. Equal Employment Opportunity Statement: We are an Equal Opportunity Employer and value diversity at our company. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected status. Department: AI Innovation - Engineering FLSA Type: Exempt Reports To: Sr. Director of AI & BI Supervision Exercised: None Supervision Received: Sr. Director of AI & BI or designee; at least quarterly. Target Compensation: $136,000 - $172,850 depending on education, experience, specifics of the position. About PaceMate® PaceMate® is a patient-centered, tech-enabled cardiac device monitoring platform serving integrated delivery networks and academic health systems nationwide. Vendor-neutral and EMR-agnostic, PaceMate connects every major device manufacturer into a single platform that sits on top of any EHR. More than 2.3 million patients are managed on the industry’s only research-grade cardiac dataset, validated by 33 peer-reviewed publications, powering AI-driven clinical and operational analytics. A managed patient services model extends clinic capacity and ensures every cardiac device patient is monitored, every time. Learn more at PaceMate.com #J-18808-Ljbffr