上海招聘

· Be familiar with and follow the departmental and company standard operating procedures (SOPs) and working practices (WPs).

· Time management of own and team's time spent on projects.

· Interact with the sponsor on statistical aspects of the project.

· Produce sample size calculations. Provide input into study design and statistical considerations, during protocol development. Review protocols for completeness, appropriateness of clinical design and sound statistical analysis.

· Contribute to writing appropriate protocol sections.

· Provide randomization schemes and appropriate documentation, on selected projects.

· Develop statistical analysis plans, including table, listing and graph specifications.

· Specify the general structure of the analysis database, provide programming support for its development and validation.

· Produce statistical analyses and statistical appendices, with appropriate documentation.

· Prepare Statistical Reports, Integrated Summaries of Safety, Integrated Summaries of Efficacy and other documents, as required. Contribute statistical methods section for Integrated Clinical Statistical Reports. Review Integrated Clinical Statistical Reports.

Qualification

1. A Master or Bachelor degree in biostatistics, statistics or related field.

2. A minimum of 1 year (for M.S.) or 2 years (for Bachelor) experience of statistical and/or statistical programming in CRO or pharmaceutical R&D including all phases and large studies applied to drug or medical device development.

Skills

1. Strong writing skills required to be able to write sections of protocols, statistical reports, clinical study reports, and randomization plans

2. SAS® programming skills and familiarity of other statistical packages (e.g. StatXact, nQuery) and understanding of database structures

3. Excellence in planning, managing and coordinating statistical and statistical programming activities in clinical trials; previous management experience of statisticians is preferred

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 ************.