上海招聘

Responsibilities

· Performs statistical activities for given clinical trials involving drugs, biologics and medical devices; provides statistical support to the project team; lead a biostatistics project term.

· Participates in clinical trial protocol development, including sample size and statistical power calculation and contribution to writing appropriate protocol sections.

· Generates randomization schedule and participate drug repackage/relabeling activity.

· Develops statistical analysis plan (SAP) including table shells design.

· Reviews protocols, SAP or other study documents developed by other statistician(s) or consultant(s) and provides comments.

· Represents statistical team at project team meetings and provides updates to project team on status of tasks.

· Writes statistical analysis report (SAR) and participates in clinical study report (CSR) writing.

· Performs other statistical review, such as case report form (CRF) design, database development, data validation plan and blinded data review report.

· Where applicable, provides input and review the specifications of the programs that produce the tables, listings, figures, and/or analysis datasets.

Qualifications

· An advanced degree (Ph.D. or M.S.) in biostatistics, statistics or related field

· A minimum of 1 years experience of statistical and/or statistical programming applied to drug or medical device development

Knowledge, Skills and Abilities:

· Good writing skills required to be able to write sections of protocols, statistical reports, clinical study reports, and randomization plans

· Good SAS® programming skills.

· Be knowledgeable in all aspects of the drug agencies (e.g. FDA, SFDA) regulations and requirements governing the conduct of drug and medical device studies including, but not limited to, GCP and ICH requirements.

· Be able to make effective presentations in public settings.

· Proficient working in a PC/Windows environment.

PPD is a leading global contract research organization providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 44 countries and more than 20,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments. For more information, visit ************.