上海招聘

Conduct basic and assist with complex statistical analysis in support of clinical research studies as specified in statistical analysis plans, including statistical graphics.
- Verify randomization codes for a basic study design and develop randomization specifications for basic and complex study designs.
- Prepare statistical sections of protocols (including sample size determinations)and statistical analysis plans.
- Prepare and annotate safety and basic and complex efficacy shell data displays.
- Provide specifications for structure, content and algorithms for safety and efficacy analysis datasets.
- Perform and quality control of data displays that show basic and complex inferential statistics.
- Perform quality control of safety and efficacy analysis datasets.
- Maintain project administration file, including protocol, annotated CRF, statistical analysis plan, annotated shells for data displays, programming and quality control rules, tracking of generation and quality control of data displays, and project communication (internal and client).
- Maintain project directories on computer systems, including ensuring that final SAS output is in the correct directory, and that all interim programs and output are deleted at the completion of the project.
- Handle miscellaneous tasks as assigned by management.
- Able to review case report (CRF)design, data management plan, and edit specifications for a clinical trial.
- Able to review clinical study report (CSR)for staistical concerns.
- Able to provide input to standard operating procedures (SOP)and audits.
- Able to mentor new hire statisticians.
- Able to propose solutions to problems that arise while proforming tasks.
- Perform quality control of datasets and data displays for integrated summary of safety and efficacy.
- Produce quality deliverable within timelines and with customer satisfaction.
- Develop effective time management skills

Established in 1985, Theorem Clinical Research is one of the industry’s leading full-service, global CROs. Theorem provides core CRO services for Phases I to IV, but with niche business units in the areas of Technical Services, Medical Device and Pharmaceutics.

So what makes us different? Theorem can manage even the most complex project--from study design to product launch and beyond. Our clients see us as “the right size” CRO—big enough to successfully manage your large global trials, but with a personalized service level you might associate with a smaller organization. And we execute with speed, flexibility and an attention to detail that drives high-quality performance. Additionally, we have unique strengths in Asia Pacific and Latin America.
Our comprehensive clinical service offering includes the following:

?    Project Management
?    Clinical Monitoring*
?    Clinical Data Management*
?    Regulatory Affairs*
?    Clinical Quality Assurance
?    Safety Surveillance/Pharmacovigilance*
?    Biometrics*
?    Clinical Writing
?    Investigator Agreements
?    Medical Affairs
?    Patient Recruitment

The Theorem Clinical Research name is new. But it is built on a long history of delivering exceptional services and support for all phases of clinical research. Before launching in 2011, Theorem Clinical Research operated for nearly two decades as Omnicare Clinical Research under the Omnicare, Inc. parent company. Dating back to the late 1990s, Omnicare Inc. acquired several smaller CROs—including Coromed and IBAH—and launched Omnicare Clinical Research in the year 2000.

Today, we have grown into a global organization with 900+ employees located throughout 27 countries. As our story continues to unfold, one factor remains constant: our people are committed to our clients and their success. For that reason, we strive to enhance our business on an ongoing basis. Whether it’s by opening a new office location, implementing a new technology, or maximizing a strategic new partnership, Theorem Clinical Research understands how to meet your evolving drug development needs.