Biostatistician Ii

JOB DESCRIPTION
The Biostatistician II, Medical Affairs, will be responsible for providing statistical analysis activities for Medical Affairs. These activities include creating, reviewing, and maintaining statistical analysis strategies, performing the statistical analyses, providing data interpretation, and participating in the preparation of summarizations of the outcomes (e.g. posters, manuscripts, etc.).
Job Duties:

• Provide statistical input including development of study design/data collection, formulating study endpoints, implementing appropriate statistical analysis methods
• Perform sample size and power calculations
• Review statistical section of study reports
• With guidance, prepare and maintain statistical analysis strategies for individual studies ensuring that appropriate statistical methods are utilized
• Represent Biostatistics in study and project team meetings
• Perform the high-quality statistical analysis and deliver accurate, interpretable summaries
• Assist in the development of standardized processes and procedures for Statistical Analyses in Medical Affairs.
• Assist in the development of standardized data collection modules and procedures in Medical Affairs.
• Maintain study documentation of statistical analyses and supportive documents
• Ensure adherence to industry standards, including but not exclusive to Good Clinical Practices (GCP) and ICH guideline on Statistical Principles for Clinical Trials as applicable

Requirements:

• Experience working in Pharmaceutical/ Medical Device/ Biotechnology/ CRO industry as a Biostatistician is required (≥2 years with MS degree, BA/BS degree and a minimum of 2 years of related experience
• Proficient with SAS programming
• Knowledge of the drug development process
• Basic knowledge of standards for statistical applications in the conduct of Clinical Research
• Knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs
• Development and maintenance of expertise in state-of-the-art statistical methodology
• Exercises sound judgment within defined procedures and practices to determine appropriate action, seeks clarification and guidance
• Communicates effectively to build collegial, productive working relationships
• Ability to learn and utilize new methodologies
• MS in Statistics, Biostatistics or other related discipline is required

Salary range: $ 82,500 - 107,200
ABOUT US
Founded in 1998, Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.
Our company was the first company to bring to market Micro-Invasive Glaucoma Surgery (MIGS), the micro-invasive procedure which revolutionized the treatment and management of glaucoma. In 2012, we launched our first MIGS device-the iStent®-in the United States, followed by our next-generation iStent inject® device in September 2018 and iStent inject® W in September 2020.
In November 2019, Glaukos acquired Avedro, maker of the first and only FDA-approved cross-linking technology for progressive keratoconus. And we continue to seek to leverage our platform technologies to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical therapies for glaucoma, corneal health, and retinal diseases.
Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol "GKOS". Our global headquarters is located in San Clemente, California with additional locations in Waltham and Burlington, Massachusetts.
Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employmentwithout regard to race, color, religion, sex including sexual orientation and genderidentity, national origin, disability, protected Veteran Status, or any othercharacteristic protected by applicable federal, state, or local law.