Glaukos Corporation
Sr Biostatistician - Remote
Glaukos Corporation, San Clemente, California, us, 92674
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 methodsPerform sample size and power calculationsReview statistical section of study reportsPrepare and maintain statistical analysis plans (SAP) for individual studies, ISS and ISE ensuring that appropriate statistical methods are utilizedCreate shells (mock-ups) for tables, listings, and figuresRepresent Biostatistics in study and project team meetingsCollaborate with Statistical Programming on the implementation of the SAPConduct statistical analyses and perform SAS programming, as neededProvide 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 documentsEnsure adherence to industry standards and regulatory requirements, including but not exclusive to Good Clinical Practices (GCP) and ICH guideline on Statistical Principles for Clinical TrialsEnsure 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 (>= 2 years with PhD degree; >=4 years with MS degree)Proficient with SAS programming and other statistical software (e.g., R, PASS)Knowledge of the drug development process
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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 methodsPerform sample size and power calculationsReview statistical section of study reportsPrepare and maintain statistical analysis plans (SAP) for individual studies, ISS and ISE ensuring that appropriate statistical methods are utilizedCreate shells (mock-ups) for tables, listings, and figuresRepresent Biostatistics in study and project team meetingsCollaborate with Statistical Programming on the implementation of the SAPConduct statistical analyses and perform SAS programming, as neededProvide 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 documentsEnsure adherence to industry standards and regulatory requirements, including but not exclusive to Good Clinical Practices (GCP) and ICH guideline on Statistical Principles for Clinical TrialsEnsure 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 (>= 2 years with PhD degree; >=4 years with MS degree)Proficient with SAS programming and other statistical software (e.g., R, PASS)Knowledge of the drug development process
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