Biostatistics Sr Mgr

What you will do

In this vital role you will achieve results through detailed goal setting, accountability measures, effective partnership, performance management, collaboration with other groups and a dedication to serving customers, both inside and outside of Global Study Operations (GSO).

The Senior Biostatistics Manager independently leads sophisticated studies and projects in the oncology therapeutic area, ensuring that the statistical aspects of clinical activities meet required standards and are robust and valid. Will also influence and supply to strategy development, defend statistical approaches and represent GBS through participating in and collaborating with multidisciplinary project teams.

• Utilizing knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, reimbursement, and medical affairs.
• Implementing, managing and supporting standards, technical quality and consistent approaches in strategy, study design and statistical analysis.
• Planning and executing statistical contributions to protocols, Flash Memos and Clinical Study Reports (CSRs).
• Providing input for clinical publications and regulatory filing documents.
• Leading all aspects of work performed by study statisticians.
• Performing statistical and exploratory analysis of studies/projects and developing conclusions and recommendations.
• Anticipating and communicating resource and quality challenges that could impact results or timelines.
• Solid understanding of regulatory guidelines in oncology drug development.
• Staying current in developments in the field of statistics in drug development (innovative trial design) and Amgen's statistical policies, procedures and strategies.
• Contributing to process improvements and operational efficiencies.

Basic Qualifications

Doctorate degree

Or Master's degree and 4 years of Biostatistics experience

Or Bachelor's degree and 6 years of Biostatistics experience

Preferred Qualifications

• Doctorate degree in biostatistics or statistics.
• 5 or more years of pharma/biotech statistical experience.
• Life cycle drug development experience (pre-clinical, clinical and post-marketing).
• Experience with oncology drug development.
• Proven in leadership and motivating multi-functional team to advance complex projects to completion and thoughtfully negotiate and influence
• Strong verbal and written communication combined with organizational skills and cross-cultural sensitivity
• Statistical leadership and contribution to regulatory and reimbursement submissions.
• Strong working knowledge of theoretical and applied statistics and of regulatory guidelines.
• Experience working effectively in a globally dispersed team environment with cross-cultural partners.