Sr. Biostatistician

<strong>At Glaukos, our focus is to develop and lead the global ophthalmic market with novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases&mdash;therapies that advance the existing standard of care and enrich the lives and treatment alternatives for patients worldwide.<br /><br />Help put the next wave of disruptive technologies on the market. Work with a team that&rsquo;s dedicated to making a difference in the lives of patients worldwide.<br /></strong>

Aliso Viejo, CA


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. <br /><br />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.<br /><br />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.

keywords: analysis,creative,analysis,quality assurance,create,represent,prepare,performance,teamwork,develop,maintenance,research,knowledge,experience,software development,degree

Full time

Overview: The&nbsp;<strong>Biostatistician</strong>, based in&nbsp; Aliso Viejo, CA will be responsible for statistical analysis activities for assigned clinical studies. These include creating, reviewing, and maintaining statistical analysis plans, performing statistical analyses, providing data interpretation and participating in protocol development and the preparation of clinical study reports.
Responsibilities: <ul><li>Provide statistical input including development of study design, formulating study endpoints, implementing appropriate statistical analysis methods</li><li>Perform sample size and power calculations</li><li>Author statistical section of study protocols and study reports</li><li>Prepare and maintain statistical analysis plans (SAP) for individual studies, ISS and ISE ensuring that appropriate statistical methods are utilized</li><li>Create shells (mock-ups) for tables, listings, and figures</li><li>Represent Biostatistics in study and project team meetings</li><li>Represent Biostatistics in meetings with regulatory agencies</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>Review registration documents and publications to ensure data interpretation is statistically sound and accurate and consistent with data presentation</li><li> Develop or 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>PhD or MS in Statistics, Biostatistics or other related discipline is required</li><li>Experience working in Pharmaceutical/ Medical Device/ Biotechnology/ CRO industry as a Biostatistician is required (>= 4 years with PhD degree; >=6 years with MS degree)</li><li>Proficient with SAS programming and other statistical software (e.g., R, PASS)</li><li>Experience with regulatory submissions</li><li>Knowledge of the drug development process</li><li>Basic knowledge of global regulatory requirements and 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 and regulatory requirements</li><li>Ability to learn and utilize new methodologies </li></ul>