Senior Biostatistician
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Job Description
Senior Biostatistician supporting ophthalmic clinical trial design, analysis, and reporting at Lexitas. Ensuring statistical integrity across clinical studies, submissions, and publications.
Responsibilities:
- Inform the design, collection, analysis, reporting, interpretation, and publication of clinical trial data
- Maintain a basic understanding of industry and academic developments in biostatistical methodology, regulatory trends, and ophthalmology
- Support the development and rollout of new innovations, standards, processes, and efficiencies within Biostatistics
- Provide scientific and technical consultation and collaborate with internal and external stakeholders
- Support collaboration with Data Management
- Review clinical trial data and validate key endpoints or datasets
- Represent Lexitas in interfaces with Sponsors and vendors
- Ensure consistency and adherence to standards and departmental SOPs
- Ensure the statistical integrity of deliverables
- Author sections of protocols, statistical analysis plans, CSRs, presentations, and publications of clinical trial data
- Lead, manage, and support statistical activities for clinical studies, submissions, and development initiatives
- Track and escalate concerns related to changes in scope of services
- Mentor junior biostatisticians
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
- Ability to perform the stated physical requirements, including lifting and carrying 10–35 pounds
- Equivalent experience, skills, and/or education will also be considered
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