Sr Biostatistician - Remote

<p class=""p1"">Here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve the eyesight of people worldwide. Because we&rsquo;re a rapidly growing company with a dynamic, fast-paced culture, employees here are empowered with more diverse and enriching challenges than might not be possible at a larger company.</p> <br /><br />Base Salary Range: $109,100 - $141,800

United States


<h4>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.</h4> <h4>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&mdash;the iStent&reg;&mdash;in the United States, followed by our next-generation iStent&nbsp;inject&reg;&nbsp;device in September 2018 and iStent&nbsp;inject&reg;&nbsp;W in September 2020.</h4> <h4>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.</h4>

keywords: position summary,quality assurance,analysis,teamwork,create,assist,maintenance,knowledge

Full time

Base Salary Range: $109,100 - $141,800

Overview: Provide statistical input including development of study design, formulating study endpoints, implementing appropriate statistical analysis methods.<br />Perform sample size and power calculations.<br />Review statistical section of study reports.<br />Prepare and maintain statistical analysis plans (SAP) for individual studies, ISS and ISE ensuring that appropriate statistical methods are utilized.
Responsibilities: <ul> <li>Create shells (mock-ups) for tables, listings, and figures</li> <li>Represent Biostatistics in study and project team meetings</li> <li>Collaborate with Statistical Programming on the implementation of the SAP</li> <li>Conduct statistical analyses and perform SAS programming, as needed</li> <li>Provide statistical analyses support to publications (e.g. abstracts, presentations and posters, manuscripts)</li> <li>Assist in the development of departmental processes and procedures.</li> <li>Maintain study documentation of statistical analyses and supportive documents</li> <li>Ensure adherence to industry standards and regulatory requirements, including but not exclusive to Good Clinical Practices (GCP) and ICH guideline on Statistical Principles for Clinical Trials</li> <li>Ensure that Glaukos statistical/programming policies, guidelines, and procedures are followed</li> </ul>
Requirements: <ul> <li>Basic knowledge of standards for statistical applications in the conduct of Clinical Research</li> <li>Knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs</li> <li>Maintains expertise in state-of-the-art statistical methodology&nbsp;</li> <li>Ability to learn and utilize new methodologies</li> </ul>