Overview

Inform the design, collection, analysis, reporting, interpretation, and publication of clinical trial data

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
• Leads, manages, and supports statistical activities for clinical studies, submissions, and development initiatives
• Tracks and escalates concerns related to changes in scope of services
• Mentors junior biostatisticians

Requirements

Education:

• Required: Bachelor's degree or international equivalent in Biostatistics, Statistics, or related field
• Preferred: Master's degree or equivalent in Biostatistics, Statistics, or related field

Experience:

• 5 or more years of experience in statistical analysis within clinical research, preferred

Skills:

• 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

Physical Requirements

Position requires: ordinary ambulatory skills and physical coordination sufficient to move about conference or meeting locations as required; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. Lexitas Pharma Services, Inc., at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. Lexitas Pharma Services, Inc., at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

The pay range for this role is:

135,000 - 155,000 USD per year (Remote (United States))