Director, Biostatistics and Statistical Programming

September 27

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Lexitas

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Litigation Support Services • Deposition Services • Court Reporting • Records Retrieval • Realtime Reporting

501 - 1000

💰 Debt Financing on 2016-09

Description

• 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. • 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

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