Director, Biostatistician & Data Management

Glaukos is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world's leading causes of blindness. We have pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. We launched the iStent, our first MIGS device, in the United States in July 2012 and we are leveraging our platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. We believe the iStent is the smallest medical device ever approved by the Food and Drug Administration, or FDA, measuring 1.0 mm long and 0.33 mm wide.

Position Overview:

The Director, Biostatistics & Data Management role, based in San Clemente, California is responsible for managing and leading the data management and biostatistics function for the organization. Provides statistical expertise to the clinical development program for assigned projects to ensure that scientifically valid conclusions are drawn concerning claims with respect to efficacy and safety of the products that are under development. The Biostatistician supports all statistical activities in all phases of projects related clinical development and is expected to play an active role in multi-disciplinary project and study teams. Will represent the organization at Regulatory meetings and provide input to study design and data capture.

Responsibilities:

• Participate in Clinical Study Team meetings for assigned studies

• Responsible within the Clinical Study Team for the quality, accuracy and timely completion of assigned tasks

• Responsible for making statistic model selection, experimental design, design and analysis of clinical trials

• Analyze and interpret data from individual trials

• Perform meta-analyses by pooling data from several studies

• Develop project analysis plan, including computer-generated table specifications, statistical analysis plan, and research report format

• Cooperate in further development of internal guidelines and SOPs

• Responsible for data processing for accurate relocation, formatting, generating and transmitting required data

• Prepare statistical contribution to Integrated Study Report




Work Experience:

• Experience in Biostatistical Analysis & SAS for clinical trials in the medical device

• Strong data management background

• Pharmaceutical, medical device or biotechnology industry.

• Minimum 5 years of statistical analysis experience in a

• Clinical trials environment

• Update knowledge in statistical concepts, methods, and techniques

• Maintain state of the art statistical applications in clinical research

• Strong communication skills, both written and verbal

• Maintains strong attention to detail in high-pressure situations

• Solid understanding of business practices with fundamental understanding of project

management methodology

• Requires excellent computer skills

• Candidate must have sound knowledge of the application of advanced statistical methods in clinical research gained through experience and education.

Education:

• Bachelors in math or statistics, or experience in a related subject with a high statistical content.

• Advanced degree (Ph.D. preferred) in Biostatistics or Statistics with at least 5 years' experience in clinical research in a biopharmaceutical or academic setting is required.

We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, 3 weeks paid time off, 13 company paid holidays, Employee Stock Purchase Program and 2 additional paid days off to volunteer in our community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class. Check out our profile on The Muse to get an inside look at our company culture: https://www.themuse.com/companies/glaukoscorporation

Glaukos has been recognized by the Orange County Business Journal as one of the best companies to work for in in Orange County, check out page 8 at http://www.cbjonline.com/a1ocbj/lists/List-2017-OC_Best-Places-to-Work.pdf

Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.


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