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