This client is dedicated to the development of new pharmaceutical products for both US and global markets. They are a small and dynamic company who offers a good work-life balance.
Job Detail
Job Description
Duties:
· Serving as Study Statistician responsible for the development of statistical strategies, operational executions, and statistical aspects of assigned projects and studies.
· Contributing to clinical trial design, the statistical sections of study protocols, and developing and authoring Statistical Analysis Plans (SAPs).
· Overseeing CRO activities, providing clear and explicit guidance in the development and finalization of TLF shells and TLF final productions.
· Managing timelines, reviewing and verifying all deliverables, and validating primary and key analyses of the clinical study reports (CSRs) to ensure that the statistical deliverables are of high quality and compliant with Akros' SOPs and standards.
· Responsible for the statistical interpretation of data and analysis results, ensuring proper incorporation in the clinical study reports
o 30% Contribute to study design, develop statistical sections of study protocol, develop statistical analysis plan and analysis results, provide statistical consultation to clinical study team
o 20% Review and contribute to the development of study related documents/activities: protocol, CRF, database setup, data cleaning plan, clinical study report, etc.
o 20% Participate in statistical vendor selection, manage and monitor vendor activities and deliverables, review and QC the statistical output, manage and maintain the final statistical output transferred from venders
o 5% Participate in study management with project leader and study team members to ensure adherence to timelines
o 5% Contribute to the development and maintenance of standardization, process improvement, and standard operating procedures
o 10% Maintain up-to date knowledge in the application of statistical methods and the regulatory requirements in drug development
o 5% Develop and maintain in-depth knowledge regarding disease and drug mechanism of the medical specialty areas that are assigned.
o 5% Maintain and update the knowledge of the requirement of regulatory agencies for the therapeutic areas.
Requirements:
- 5 years of experience in Biostatistics in the pharmaceutical industry with a master’s degree. 3 years of experience in the pharmaceutical industry with a PhD Degree.
- Understanding of common statistical models and methods, and experienced with their applications in clinical trials, proficiency in SAS.
- Must have strong written and oral communication skills. Has the ability to work with both technical and non-technical people
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