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Position: Senior Biostatistician
Institution: Cytel Inc.
Location: Shanghai, China
Duties: You will plan and carry out statistical activities in support of our innovative clinical trials; You will develop Statistical Analysis Plans (SAP) and create table, listing and figure shells, and review Case Report forms (CRFs/eCRFs); You will perform statistical analysis as defined in the SAP, plan the design and analysis for our clinical trials, provide statistical input to clinical study reports, and provide statistical support to drug safety, medical affairs and pharmacology; Contribute to clinical protocol development, including authoring of the section on statistical methods and reviewing/editing of other sections by applying statistical principles
Requirements: You have a PhD or Master’s degree in biostatistics or statistics, with at least 2 years (PhD) or 4 years (Master) of oncology experience in an CRO or the pharmaceutical industry, preferably with oncology late phase and submission experience; You have a good understanding of drug development processes and regulatory requirements, including ICH/GCP guidelines; You have expertise in using statistical programming software (e.g., SAS, R); You have a growth mindset, are a lifelong learner, and are energized by the idea of challenging existing thinking
   
Text: Press Tab to Move to Skip to Content Link About Us Job Locations View All Jobs Join Talent Community View Profile Search by Keyword Show More Options Search by Location Send me alerts every days Share this Job Senior Biostatistician Date: Jan 26, 2022 Location: Shanghai, CN Company: Cytel Inc Senior Biostatistician The Senior Statistician is responsible for leading and supporting statistical activities for clinical studies, participating in protocol development and executions, ensuring compliance with SOPs to produce quality and timely statistical deliverables. This position reports to the Director/Sr. Director, Biostatistics. Key Responsibilities: You will plan and carry out statistical activities in support of our innovative clinical trials. You will develop Statistical Analysis Plans (SAP) and create table, listing and figure shells, and review Case Report forms (CRFs/eCRFs). You will perform statistical analysis as defined in the SAP, plan the design and analysis for our clinical trials, provide statistical input to clinical study reports, and provide statistical support to drug safety, medical affairs and pharmacology. Contribute to clinical protocol development, including authoring of the section on statistical methods and reviewing/editing of other sections by applying statistical principles Provide oversight of CROs for outsourced statistical activities and verify key results generated by CROs Perform ad hoc and exploratory statistical analyses as needed Support regulatory submissions as needed Support the preparation of publications, including manuscripts, posters and oral presentations Minimum Requirements: You have a PhD or Master’s degree in biostatistics or statistics, with at least 2 years (PhD) or 4 years (Master) of oncology experience in an CRO or the pharmaceutical industry, preferably with oncology late phase and submission experience. You have a good understanding of drug development processes and regulatory requirements, including ICH/GCP guidelines. You have expertise in using statistical programming software (e.g., SAS, R) You have a growth mindset, are a lifelong learner, and are energized by the idea of challenging existing thinking. You are an expert communicator and are adept at explaining complex topics to stakeholders with a variety of non-technical backgrounds. You can participate and work effectively on multiple cross-functional teams. You have strong interpersonal skills - you understand relationships are key and are a team player who is willing to roll-up your sleeves and get the job done. Find similar jobs: View All Jobs Cytel Home Careers Home View All Jobs Our Blog Privacy Policy © Copyright 2020
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