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Thứ Sáu, 27 tháng 3, 2015

Biostats Specialist - Advanced Clinical - Watchung, NJ

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OVERVIEW

Responsibilities include, but not limited to:



  • 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 Company 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. ]]




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