BASIC QUALIFICATIONS

Doctorate degree
OR
Master’s degree and 2 years of statistical experience
OR
Bachelor’s degree and 4 years of statistical experience
OR
Associate’s degree and 8 years of statistical experience
OR
High school diploma / GED and 10 years of statistical experience

PREFERRED QUALIFICATIONS

• Master’s degree in Statistics/Biostatistics or other subject with high statistical content, and 2 years of post-graduate statistical experience in the pharmaceutical industry or medical research or
• Doctoral degree in Statistics/Biostatistics or other subject with high statistical content
• Ability to provide sound strategic and statistical input on study/research design to meet project needs, regulatory and scientific requirements
• Ability in presenting results and defending statistical findings, study design and analysis. This could be to internal audiences (study/product team) or at external meetings such as investigator meetings, steering committee meetings, ad board meetings or regulatory meetings
• Ability in working within a global team and with CRO partners to ensure operational excellence and efficiencies
• Demonstrated effective communication skills (written and oral)

• Provides statistical contributions, statistical review and quality control of Study Concept Documents (SCDs), protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph (TLG) shells, Submission Data File (SDF) specifications, other key-study related documentation, protocol deviations, Data Quality Review (DQR), Flash Memos, Clinical Study Reports (CSRs), clinical publications, and other communications in close partnership with CROs in a full-service CRO model.
• Influences study design and defends statistical approaches internally and externally.
• Ensures all statistical aspects of documentation pertaining to clinical activities meet required standards and are statistically correct.
• Oversees the work of outsourcing partners and vendors for statistical services.
• Performs statistical analysis of individual 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. provide 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 and industry practice
• Stays abreast of latest developments in the field of statistics in drug development and contributing to scientific advances by publishing applied research in scientific journals and books and presenting statistical methodology at internal or external scientific meetings.
• Participates in the review of CRO Policies, SOPs and other controlled document development; contributes to process improvement and operational efficiency.
• Adheres to all Amgen Policies, Standard operation procedures (SOPs) and other standards which are applicable to biosimilar development.