Biostatistician

Summary

Lexitas Pharma Services is an ophthalmic product development organization seeking a Biostatistician to support the design, collection, analysis, reporting, interpretation, and publication of clinical trial data. The role contributes to statistical methodology, validates clinical trial endpoints and datasets, collaborates with stakeholders, and ensures the integrity and compliance of statistical deliverables.

Responsibilities

• Maintains a basic understanding of industry and academic developments in biostatistical methodology, regulatory trends, and ophthalmology
• Supports the development and rollout of new innovations, standards, processes, and efficiencies within Biostatistics
• Provides scientific and technical consultation and collaborates with internal and external stakeholders to facilitate understanding of statistical services and product. Supports collaboration with Data Management
• Reviews clinical trial data and validates key endpoints or datasets
• Represents Lexitas in interfaces with Sponsors and vendors
• Ensures consistency and adherence to standards and departmental SOPs
• Ensures the statistical integrity of all deliverables and authors appropriate sections of protocols, statistical analysis plans, CSRs, presentations, and publications of clinical trial data

Skills

• Required: Bachelor's degree or international equivalent in Biostatistics, Statistics, or related field
• Basic understanding of statistical topics and methodology in drug and medical product development
• Excellent technical and programming logic skills
• Experience with cross-functional collaboration
• Excellent verbal and written communication skills
• Good planning and organizational skills with the ability to adapt and adjust to changing priorities
• Ability to be productive and handle multiple tasks to meet deadlines in a dynamic, fast-paced environment
• Strong interest in developing expertise in ophthalmology
• Preferred: Master's degree or equivalent in Biostatistics, Statistics, or related field
• 1 or more years of experience in statistical analysis within clinical research, preferred

Qualifications

Must Haves

• Required: Bachelor's degree or international equivalent in Biostatistics, Statistics, or related field
• Basic understanding of statistical topics and methodology in drug and medical product development
• Excellent technical and programming logic skills
• Experience with cross-functional collaboration
• Excellent verbal and written communication skills
• Good planning and organizational skills with the ability to adapt and adjust to changing priorities
• Ability to be productive and handle multiple tasks to meet deadlines in a dynamic, fast-paced environment
• Strong interest in developing expertise in ophthalmology

Nice to Haves

• Preferred: Master's degree or equivalent in Biostatistics, Statistics, or related field
• 1 or more years of experience in statistical analysis within clinical research, preferred