Amgen Biostatistics Sr Mgr in Shanghai, China
The Biostatistics Senior Manager reports to Biostatistics Director, Asia regional head of Global Biostatistics Science. This role serves as the regional biostatistics Therapeutic Area lead for cardiovascular disease, nephrology and neuroscience, and is responsible for the biostatistical activities in covered products. This role independently leads multiple products/studies, 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.
Execute key projects, deliverables and operational tasks related to biostatistical strategy, technical expertise, and reporting within designated studies / products
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 operation procedures (SOPs). Basic Qualifications
Doctorate in Statistics/Biostatistics and post-graduate statistical experience in the pharmaceutical industry or medical research or related subject with high statistical content and
At least 4 years of post-graduate statistical experience in the pharmaceutical industry or medical research
At least 6 years of post-graduate statistical experience in the pharmaceutical industry or medical research
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)