Senior Commercial Underwriting Counsel
CRC Insurance Services
Salary
💰 $150,000 - $165,000 per year
Job Level
Senior
About the role
- 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 to facilitate understanding of statistical services and product
- 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 all deliverables and author appropriate sections of protocols, statistical analysis plans, CSRs, presentations, and publications
- 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
- 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
- 5 or more years of experience in statistical analysis within clinical research, preferred
- 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: ordinary ambulatory skills; ability to stand, walk, stoop, kneel, crouch periodically; lift/carry 10-35 pounds; arm, hand and finger dexterity including typing for prolonged periods; visual acuity; ability to sit, reach, talk, and hear for prolonged periods
- Equivalent experience, skills, and/or education will be considered
