Director of Biostatistics Process Excellence - Mabie, CA, United States - SilverLinx

SilverLinx
SilverLinx
Verified Company
Mabie, CA, United States

3 days ago

James Miller

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James Miller

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Freelance
Description

Mabie, CA - Director Biostatistics Process Excellence
Proclinical is collaborating with a biotech company in their search for a new team member. This is a permanent position located in Frankfurt.

The ideal candidate will be joining as the Director of Biostatistics Process Excellence, with a focus on improving the lives of many.


Responsibilities:


  • Lead GBD process development initiatives to identify the most effective strategies for improving GBS efficiency.
  • Conduct quality measure analysis, including performance development and documentation, and provide recommendations to the GBS leadership team.
  • Ensure compliance with regulatory requirements, such as ICH, FDA, EMA, and GCP regulations.
  • Develop and enhance biostatistical procedures and standards for clinical trials.
  • Other duties may be assigned as needed.

Key Skills and Requirements:


  • Advanced degree in biostatistics or a related field.
  • Minimum of 15 years of experience in a relevant discipline, such as biostatistics, within a pharmaceutical/biotech organization.
  • At least 5 years of experience in a leadership role, with a proven track record of managing a team.
  • Understanding of the drug development process, with relevant knowledge in statistics and statistical programming.
  • Ability to lead endtoend process improvement initiatives, from ideation to realization of benefits.
  • Previous experience in project management and implementing operational excellence strategies.
  • Familiarity with working with external parties and leading crossfunctional teams.
  • Fluent in English

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