Director leading teams and strategic growth initiatives in IT sales for api GmbH. Focusing on innovation and employee development in a secure and modern workplace.
About the role
- Associate Director of Biostatistics providing technical and operational support for clinical trials in a global biopharmaceutical company. Focusing on statistical analysis and regulatory compliance.
Responsibilities
- Provides technical and operational support for the design and implementation of clinical development programs and the associated clinical trials for therapeutic areas and compounds
- Identifying optimal study designs
- Defining data analysis strategies
- Authoring and implementing statistical analysis plans
- Interpreting the resulting findings and crafting and communicating key messages to internal audiences and selected key external stakeholders
- May interact with regulatory agencies on matters related to the data for assigned clinical programs and/or trials
- Works cross-functionally with internal departments and external resources on Biostatistics related issues
- Supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate
Requirements
- Advanced degree in Statistics or a related statistical discipline
- Minimum of 7 years of progressively responsible statistical experience in a pharmaceutical, biotechnology, contract research organization (CRO) or related environment
- Hands-on experience supporting clinical studies, working with clinical teams and interacting with regulatory agencies
- Demonstrated ability to manage biostatistics deliverables at the study level
- Demonstrated understanding and working knowledge of statistical theory and its application in the pharmaceutical/biotechnology industry
- Hands-on statistical programming skills using SAS and/or R
Benefits
- medical, dental, vision, and retirement savings plans
- short- and long-term incentives
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