Position Summary: The Senior Biostatistician will play a critical role in designing statistical analysis plans for clinical studies—authoring these plans, shaping study designs, and ensuring robust statistical methodologies. Working as a key member of a multidisciplinary team of engineers and medical experts, the Senior Biostatistician will plan and provide evidence to support major product development initiatives, specifically within the domain of multi-spectral imaging integrated with advanced Artificial Intelligence algorithms for accurate, real-time wound and burn diagnostics. Essential Duties and Responsibilities: Collaborate across Functions: Work closely with Data Science, Clinical Affairs, Regulatory Affairs, Clinical, and external partners to define and clarify project requirements, design and execute clinical trials for medical devices, and standardize statistical approaches for business needs. Clinical Trial Support & Design: Support the design and implementation of clinical studies, including developing efficient trial designs, sample size calculations, randomization schemes/lists, simulation programs, and protocols (including CRFs and CIPs). Prepare and maintain accurate, detailed, and methodologically appropriate statistical analysis plans (SAPs), and provide input on effective data collection, data derivation, and blinded/unblinded data review processes.

Statistical Analysis & Reporting: Produce, review, and interpret statistical analyses and reports for internal use, publications, and regulatory submissions, including the development and review of real-world data plans and meta-analyses. Contribute to peer-reviewed articles, clinical study reports (CSRs), and prepare documentation for IRB/Ethics Committee submissions (e.g., power analyses). Assist with literature reviews, protocol deviation assessments, and preparation of information for publication or presentation at professional meetings.

Programming & Process Oversight: Provide programming instructions, review, and approve statistical programming deliverables, and ensure proper documentation, traceability, and validation in compliance with internal procedures.

Quality & Compliance: Manage statistical aspects of outsourced work, monitor data quality/performance metrics, resolve complex statistical issues, and ensure appropriate documentation and adherence to deadlines.

Communication & Consultation: Communicate and interpret statistical concepts and findings to a variety of audiences, translating complex data for non-statistical colleagues and stakeholders in a clear and concise manner. Challenge and validate data analysis results through personal expertise and collaboration. Develop, implement, and review procedures and best practices for statistical approaches, applying new methods to existing processes where appropriate.

Other Duties: Perform all other duties as assigned. Qualifications: Required education and experience: A Master’s degree (PhD preferred) in engineering, biotech, life sciences, or equivalent experience. A minimum of six years’ experience in the medical device, pharmaceutical and/or life science industry, ideally with experience developing Class II and/or Class III medical devices. Sustained record of performance in previous positions and a track record of implementing improvements. Ability to understand and implement statistical methods in the activities under responsibilities. Knowledge of statistical computer programs (e.g., R, SAS, Query, PASS, etc.). Experience working in cross functional organization. Knowledge, Skills and Abilities: Thorough understanding of descriptive statistics, hypothesis testing, non-parametric, multivariate statistical tests, survival analysis, longitudinal data analysis, and other innovative statistical methodologies. Ability to assist in selecting and applying appropriate methods and analyses in the field of application. Proficient in statistical computer programs (e.g., R, SAS, Query, PASS, etc.); familiar with other statistical packages for handling smaller datasets and power analyses. Proficient with Microsoft Office Suite (PowerPoint, Excel, Word). Highly detail-oriented with excellent organizational skills and attention to detail. Strong analytical, problem-solving, and troubleshooting skills. Excellent verbal and written communication skills. Excellent interpersonal and customer service skills. Excellent time management skills with the proven ability to meet deadlines. Ability to prioritize tasks and delegate when appropriate. Highly motivated team player adept at cross-functional collaboration. Excellent organizational skills and attention to detail. Physical Requirements: The physical demands described below are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Prolonged periods of sitting at a desk and working on a computer. Must be able to lift, up to 25 pounds at times. Travel: Up to 10 % of travel time expected for the position, overnight to clinics, vendors, or conferences. Equal Employment Opportunity: Spectral MD, Inc. is an equal opportunity and affirmative action employer. All applicants will be considered for employment without regard to race, color, ancestry, national origin, sex, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws.