Director, Biostatistics and Statistical Programming

We’re looking for purpose-driven, passionate individuals to join our team. From clinical to commercial to supporting functions, Lexitans believe in the common mission: to be the best ophthalmic product development organization to partner with. 

Overview

Serves as lead biostatistician to manage statistical deliverables and provide statistical expertise for the design, analysis, and reporting for one or more clinical trials. Serves as a subject matter expert for advanced statistical methodologies and regulatory issues and process for the department. 

Responsibilities

• Leads and manages statistical activities for clinical studies, submissions, and development initiatives
• Maintains a broad understanding of industry and academic developments in biostatistical methodology, regulatory trends, and ophthalmology
• Collaborates with internal and external stakeholders in the design, collection, analysis, reporting, interpretation, and publication of clinical trial data
• Leads in the development and rollout of new innovations, standards, processes, and efficiencies within Biostatistics
• Provides scientific and technical consultation both internally and externally to Lexitas. Collaborates with internal and external stakeholders to facilitate understanding of statistical services and product. Supports collaboration with Data Management
• Ensures the statistical integrity of all deliverables and authors appropriate sections of complex protocols, statistical analysis plans, clinical study reports, presentations, and publications of clinical trial data to meet requirements of regulatory agencies, Sponsors, and Lexitas
• Reviews clinical trial data and validates key endpoints or datasets
• Assesses changes to budgets, sets priorities, and ensures consistency and adherence to standards and departmental SOPs
• Represents Lexitas in interfaces with Sponsors, vendors, and regulatory agencies
• Represents Lexitas at professional societies, external scientific forums, and industry-wide technical discussions as a statistical expert
• Creates and maintains external relationships with academic and industry experts to stay abreast of emerging methodologies
• Serves as a subject matter expert for advanced statistical methodologies and regulatory issues and process for the department
• Mentors junior biostatisticians in statistical methodologies and relevant Lexitas SOPs

Requirements

Education:A Masters or Doctorate degree or equivalent in Biostatistics, Statistics, or other relevant scientific discipline.
Experience:A minimum of 15 years of experience supporting clinical trials for regulatory submissions with sufficient experience leading statistical activities.
Skills:

• A high level of SAS programming skills
• Moderate experience with R is a plus
• Experience with ophthalmology is preferred
• Comprehensive understanding of statistical topics in medical product development
• Excellent technical and programming logic skills
• A successful history of cross-functional collaboration
• Comprehensive knowledge of all relevant regulations and guidelines
• 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
• A 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.