Biostatistics Sr Mgr

Let’s do this. Let’s change the world. 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 CfDA (Center for Design & Analysis). The Biostatistics Senior Manager independently leads multiple products/studies in the General Medicine (Cardiometabolic, Nephrology, and Bone), Inflammation, and/or Rare Disease therapeutic areas, ensures that all statistical aspects of documentation pertaining to clinical activities meet required standards and are statistically correct, influences and contributes to the development strategy, and defends statistical approaches internally and externally.

• Executes key projects, deliverables and operational tasks related to biostatistical strategy, technical expertise, and reporting within designated studies / products.
• Utilizes knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, reimbursement, and medical affairs.
• Implements, oversees and supports standards, technical quality and consistent approaches in strategy, study design and statistical analysis.
• Plans and executes statistical contributions to protocols, Flash Memos, and Clinical Study Reports (CSRs).
• Provides statistical inputs to clinical publications and regulatory documents.
• Oversees statistical work performed by study statisticians.
• Performs statistical analysis of multiple studies/projects and subsequent exploratory analyses, and makes sound conclusions and recommendations.
• Represents the Biostatistics function and participates in multidisciplinary project team meetings; collaborates closely with other functional team members; incorporates knowledge of cross-functional areas to inform and provide sound statistical guidance to teams (e.g. provides support and input in case report form design, and data collection).
• Proactively anticipates and communicates resource and quality issues that may impact deliverables or timelines within functional area as well as cross-functionally.
• Be familiar with statistical policy and strategy at Amgen; having working knowledge of theoretical and applied statistics and of regulatory guidelines.
• Stays abreast of latest developments in the field of statistics in drug development (innovative trial design)
• Contributes to process improvement and operational efficiency.
• Adheres to all Amgen Policies, Standard operating procedures (SOPs).

We are all different, yet we all use our unique contributions to serve patients. The Biostatistical professional we seek is an emerging leader with these qualifications.

Basic Qualifications

• Doctorate degree in Statistics/Biostatistics and at least 2 years of post-graduate statistical experience in the pharmaceutical industry or medical research or related subject with high statistical content
• Master’s degree in Statistics/Biostatistics and at least 6 years of post-graduate statistical experience in the pharmaceutical industry or medical research or related subject with high statistical content

Preferred Qualifications

• Doctorate degree in Statistics/Biostatistics and at least 5 years of post-graduate statistical experience in the pharmaceutical industry or medical research or related subject with high statistical content
• Master’s degree in Statistics/Biostatistics and at least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research or related subject with high statistical content
• Statistical leadership and contribution to regulatory or reimbursement submissions
• Experience working effectively in a globally dispersed team environment with cross-cultural partners
• Excellent oral and written English communication skills
• Ability to manage self, lead and manage others in the successful and timely completion of all statistical activities for a study or multiple studies from end to end
• Ability to effectively perform complex statistical analyses and related tasks
• Life Cycle Drug Development Experience (Pre-clinical Development, Clinical Development, and Post-marketing)
• Proven in leadership and motivating multi-functional team to advance complex projects to completion and thoughtfully negotiate and influence