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

Use statistical programming software to develop datasets and tables, figures, and listings that comply with regulatory standards and support the analysis, reporting, interpretation, and publication of clinical trial data

Responsibilities

• Ensures that statistical deliverables (tables, figures, listings) and study datasets (SDTM, ADaM) are programmed and validated in accordance with standards requirements of regulatory agencies, Sponsors, and Lexitas’ SOPs
• Assesses study datasets and resolves deviations from CDISC using Pinnacle21 or other quality tools
• Maintains a basic understanding of relevant industry trends in standards implementation, clinical statistical programming, and ophthalmology
• Provides technical consultation and collaborates with internal and external stakeholders to facilitate understanding of statistical programming services. Supports collaboration with Data Management to facilitate SDTM development
• Develops programming efficiencies (eg, local macros) to ensure efficient programming work
• Supports the development and rollout of new innovations, standards, processes, and programming efficiencies within Biostatistics
• Develops specification documents for datasets, and all other supporting documents (eg, define.xml, annotated CRFs, reviewer’s guides) as detailed in Lexitas’ SOPs
• Develops programming efficiencies (eg, global macros) to ensure consistent and efficient work across studies
• Leads and manages statistical programming priorities and task assignments for clinical studies and submissions
• Tracks and escalates concerns related to changes in scope of services
• Mentors junior statistical programmers
• Represents Lexitas in interfaces with Sponsors, vendors, and regulatory agencies
• Represents Lexitas in audit proceedings
• May support business development initiatives and assist director in setting department priorities and managing timelines and task assignments

Requirements

Education:

Preferred: Bachelor’s or Master’s degree or international equivalent in Biostatistics, Statistics, or programming-related field

Experience:

10 or more years of experience supporting clinical trials for regulatory submissions with sufficient experience as a study or program lead, preferred

Skills:

• A high level of SAS programming skills including SQL and macro development
• Good knowledge and application of CDISC standards for SDTM and ADaM
• Experience with Pinnacle21 and writing reviewer’s guides is a plus
• Basic understanding of standard statistical methodologies is expected
• Experience with ophthalmology is preferred
• Good understanding of statistical programming topics in medical product development
• Excellent technical and programming logic skills
• A successful history of cross-functional collaboration
• Sound 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.