Provide statistical support to publication activities. This includes ad hoc analysis, review documents and provide input.
Support the review of investigator initiated trials.
Review protocol/CRF and provides statistical input.
Participate team meetings and effectively communicate with cross-functional team members.
Provide technical expertise and support to Data Management team.
Work effectively with BDO programmers in problem solving.
Interact with CROs and ensure that Celgene’s standards are met.
Review statistical analysis plan (SAP), table shells, analysis dataset specifications and all deliverables for Medical Affairs studies provided by CRO.
Skills/Knowledge Required:
Master degree or equivalent in a relevant scientific discipline with a minimum of five years experiences.
Experiences in managing clinical programmers. Will deal with multiple programmers for different studies/projects and must be able to manage/organize to have effective communication for deliverables
Good communication skills: ability to work in a team environment with data managers, medical personnel, clinical monitors, statisticians, programmers, and medical writers.
Good Knowledge of FDA/ICH guidelines and industry standard practices.
Good skill of SAS programming.
Knowledge and skill of MS Office program suite.
Required experience:
Managing Clinical Programmers, FDA/ICH Guidelines & Industry Standard Practices, SAS Programming: 5 years
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Please review all application instructions before applying.
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