Manager, Statistical Programming and Clinical Analytics
About The Position
The Manager, Statistical Programming and Clinical Analytics is a working manager role responsible for leading statistical programming and clinical analytics activities across ReCor Medical clinical studies. This role remains primarily hands on, with approximately 70% of time focused on programming and analytics delivery and 30% focused on leadership, cross functional partnership, technical mentoring, standards, and process improvement. Responsibilities include analysis datasets, tables, listings, figures, statistical outputs, automated reporting, regulatory submission support, publication analyses, and reusable programming tools for clinical trials, registries, post approval studies, and real world evidence programs. The Manager serves as a key cross functional partner to Data Management, Clinical Operations, Scientific Affairs, Medical Affairs, Marketing, Regulatory Affairs, and Biostatistics to ensure timely delivery of high quality analyses, reporting, evidence generation, and business insights.
Requirements
- Bachelor's degree in statistics, computer science, life sciences, or a related field with a minimum of 8 years of relevant statistical programming, clinical programming, or clinical analytics experience, or equivalent combination of education and experience.
- Advanced proficiency in R is required; experience with SAS, Python, and SQL is preferred.
- Strong experience programming, validating, reviewing, and approving analysis datasets, tables, listings, figures, and statistical outputs for clinical studies.
- Experience using Git and GitHub for source control, peer review, code review, validation traceability, and collaborative programming workflows.
- Comprehensive understanding of clinical trial processes, clinical data flow, CDISC standards, and regulatory expectations for programming deliverables.
- Experience supporting regulatory submissions, clinical study reports, publications, real world evidence programs, or evidence generation activities.
- Demonstrated experience working cross functionally with clinical, scientific, medical, regulatory, and commercial stakeholders.
- Prior people leadership or technical mentoring experience preferred.
Nice To Haves
- Experience developing reusable R packages, Python packages, SAS macros, SQL libraries, or statistical programming frameworks.
- Experience with automated testing, reproducible programming practices, and programming quality controls.
- Experience with Medidata Rave, clinical data integrations, or cloud based data platforms.
- Knowledge of AI enabled analytics or automation solutions applicable to clinical data quality, risk detection, statistical reporting, or operational analytics.
- Experience supporting medical device trials, post approval studies, registries, or real world evidence programs.
Responsibilities
- Lead statistical programming activities supporting clinical trials, registries, post approval studies, real world evidence programs, and regulatory submissions.
- Program, validate, review, and maintain analysis datasets, tables, listings, figures, statistical outputs, dashboards, and reporting packages.
- Partner with Data Management to support data quality, data review, database lock readiness, and clinical study reporting.
- Collaborate with Clinical Operations on study performance metrics, enrollment reporting, site analytics, operational dashboards, and risk identification.
- Partner with Scientific Affairs, Medical Affairs, and Marketing to support evidence generation, publication analyses, congress presentations, investigator materials, commercial evidence needs, and business insights.
- Collaborate with Biostatistics on analysis requirements, output specifications, statistical review, and interpretation of programming deliverables.
- Support clinical study reports, regulatory submissions, manuscripts, abstracts, posters, presentations, and publication related analyses.
- Use Git and GitHub based workflows for source control, code review, version management, validation traceability, and collaborative development.
- Develop reusable R based tools, SAS macros, Python scripts, SQL queries, and automated reporting solutions to improve efficiency, quality, and scalability.
- Establish and maintain programming standards, validation procedures, quality controls, reusable templates, and documentation practices.
- Manage, mentor, and develop programming staff and external programming partners while remaining a senior technical contributor.
- Other duties as assigned.
Benefits
- Background Screening & Drug Testing
- Washington Fair Chance Act Compliance (if applicable)
- New Hire Training
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What This Job Offers
Job Type
Full-time
Career Level
Manager
