Senior Statistician

Job Description

Job Description

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).

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.

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

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

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.

Qualifications :

Required education and experience :

Knowledge, Skills and Abilities :

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.

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.