Biostatistician

SUMMARY 

As a Biostatistician in at EyeCare Partners, you will be working to ensure the clinical data and statistical analysis results delivered meets industry, regulatory and quality standards. The Biostatistician will provide study- and project-level statistical support for clinical studies in assuring appropriate design, analysis and interpretation of results, and contributing to regulatory submissions and negotiations. This position will evaluate standardized clinical process for regulatory and accreditation requirements. 

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Manage the statistics support to one or more projects/sponsor programs of work, ensuring that needs are fully met by expert and timely statistical consultancy and support.
• Provides expert review of study designs, analysis plans and reports.
• Assist sponsors in the design of clinical trials, including statistical sections of the study protocol, methodology and writing statistical analysis plans.
• Liaise with internal departments, sponsors and other third parties regarding statistical issues and reporting requirements.
• Perform independently as a Project Statistician for routine projects or projects with BI experience.
• Provide statistical support for research and development Clinical studies at the study and project level, & in compliance with BI/regulatory guidelines.
• Contribute to design of Clinical studies of increasing complexity in alignment with appropriate statistical methodology, project objectives and regulatory standards, conforming to R&D, marketing and/or publication strategies. 
• Manage study parameters to provide efficient, effective and optimally sized studies, which will provide sufficient data for regulatory submissions.
• Prepare/review reports for clinical trials of moderate complexity for registration of drugs and biologics, publications and management to ensure appropriate analyses and interpretation of results. 
• Evaluate alternative designs, analysis methods, and statistical theory as relevant to projects. 
• Pursue and apply industry innovations and comply with shifts in regulatory landscape. 
• Participate in internal or external working groups.
• Provide statistical expertise to the Biostatistics group regarding technical, scientific, or industry-related topics that could be applied for more efficient and effective use of resources. Align proactively with global colleagues where appropriate.
• Establishes metrics and goals/success criteria and milestones.
• Develop knowledge and skills to reinforce the ECP Mission, Vision and Values with leaders and employees.
• Participate or lead special projects and other duties as assigned.

QUALIFICATIONS

• Experienced professional statistician with Statistics Qualifications (CSTAT)
• Expertise in particular scientific disciplines related to healthcare is required.  Specifically in Ophthalmology is highly desirable.
• Demonstrated ability in programming and supporting the analysis of data using mixed models and categorical methods.
• Knowledge of statistical theory and application of statistical methodologies in study design and data analysis is required.
• Effective written and verbal communication with the ability to flex own style as needed to influence and drive results.
• Act as a change champion.
• Demonstrated experience effectively building relationships, influencing decisions and working with providers and leaders.
• Ability to effectively establish metrics and milestones and consistently execute on that success criteria.
• Strong problem-solving and decision-making skills.

EDUCATION AND/OR EXPERIENCE

• Doctoral (preferred) or Master’s degree in Statistical/Biostatistics
• 5+ years bioinformatics, required.
• 3+ years’ experience working in hospital quality, healthcare information management, healthcare analytics or clinical research.

LICENSES AND CREDENTIALS

• Minimum Required: CSTAT

SYSTEMS AND TECHNOLOGY 

• Proficient with Microsoft products (Excel, PowerPoint, Word), Google product.
• Experience with multiple PMR and EHR systems, preferred. 

NOTE:  Job descriptions are intended to be accurate reflections of those principal job elements essential for making fair pay decisions about jobs. Nothing in this job description restricts management right to assign or reassign duties and responsibilities to this job at any time.