What are the responsibilities and job description for the Senior Biostatistician II position at Glaukos Corporation?
How will you make an impact?
The Sr. Biostatistician will be responsible for leading statistical analysis activities for assigned clinical studies. These activities include creating, reviewing, and maintaining statistical sections of the protocol as well as statistical analysis plans, overseeing the performance statistical analyses, providing data interpretation, and participating in the preparation of clinical study reports.
What will you do?
* Provide statistical input including development of study design, formulating study endpoints, implementing appropriate statistical analysis methods
* Perform sample size and power calculations
* Review statistical section of study reports
* Prepare and maintain statistical analysis plans (SAP) for individual studies, ISS and ISE ensuring that appropriate statistical methods are utilized
* Create shells (mock-ups) for tables, listings, and figures
* Represent Biostatistics in study and project team meetings
* Collaborate with Statistical Programming on the implementation of the SAP
* Conduct statistical analyses and perform SAS programming, as needed
* Provide statistical analyses support to publications (e.g. abstracts, presentations and posters, manuscripts)
* Assist in the development of departmental processes and procedures.
* Maintain study documentation of statistical analyses and supportive documents
* 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
* Ensure that Glaukos statistical/programming policies, guidelines, and procedures are followed
How will you get here?
* Experience working in Pharmaceutical/ Medical Device/ Biotechnology/ CRO industry as a Biostatistician is required (>= 6 years with PhD degree; 8 years with MS degree)
* Proficient with SAS programming and other statistical software (e.g., R, PASS)
* 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
* Maintains expertise in state-of-the-art statistical methodology
Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.
These are just a few of the terms our employees use to describe their experiences as a part of the Glaukos family.
Those may seem like big aspirations, but 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 eyesight of people worldwide. And because we're a rapidly growing company with a dynamic, fast-paced culture, individual employees are empowered with more diverse and enriching challenges that might not be possible at a larger company, and more fulfillment in knowing every person and every task is directly tied to making a difference in the life of others.
We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, Employee Stock Purchase Program, generous time off & paid holidays as well as time-off to volunteer in the community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class! Moreover, Glaukos Corporation has been Certified as a Great Place to Work the last three years!
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.
