Inform the design, collection, analysis, reporting, interpretation, and publication of clinical trial data.
Requirements
Bachelor’s degree or international equivalent in Biostatistics, Statistics, or related field
5 or more years of experience in statistical analysis within clinical research
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
Master’s degree or equivalent in Biostatistics, Statistics, or related field
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 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
Leads, manages, and supports statistical activities for clinical studies, submissions, and development initiatives
Tracks and escalates concerns related to changes in scope of services