Biostatistics Associate Director

Role Summary

The Biostatistics Associate Director in Biosimilar Development leads large-scale programs and/or multiple complex studies, ensuring that all statistical aspects of clinical documentation meet required standards and are statistically sound. They influence development strategy, defend statistical approaches internally and externally, and provide leadership across cross-functional teams.

Responsibilities

• Implements, oversees and supports standards, technical quality and consistent approaches in strategy, study design and statistical analysis.
• Plans and executes statistical contributions to 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, Flash Memos, Clinical Study Reports (CSRs), and other communications in close partnership with CROs in a full-service CRO model.
• Provides statistical inputs to clinical publications, Clinical Summary of Safety (CSSs), Clinical Summary of Efficacy (CSEs), Clinical Overviews (COs), and regulatory documents.
• Oversees statistical work performed by CROs in a full-service CRO model.
• 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 and industry practice on biosimilar development.
• Stays abreast of latest developments in the field of statistics in drug development and contributes 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, and in the development and review of Amgen-CRO’s process maps; 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.

Qualifications

• Required: Doctorate degree and 3 years of biostats experience OR Master’s degree and 5 years of biostats experience OR Bachelor’s degree and 7 years of biostats experience OR Associate’s degree and 12 years of biostats experience OR High school diploma / GED and 14 years of biostats experience
• Preferred: Masters degree in Statistics/Biostatistics or other subject with high statistical content, and 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research
• Preferred: Doctoral degree in Statistics/Biostatistics or other subject with high statistical content, and 5 years of post-graduate statistical experience in the pharmaceutical industry or medical research
• Preferred: Knowledge/experience of biosimilars development, non-inferiority or equivalence trials
• Preferred: Statistical contributions to regulatory submissions
• Preferred: Experience in statistical methodologies related to adaptive designs (e.g., group sequential design, adaptations to treatment arm selection design, Bayesian adaptive design) and/or combined phase 1/2 or phase 2/3 design
• Preferred: Independent leadership of the design, analysis and reporting of at least 1 complex or multiple less complex studies/projects within the Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia
• Preferred: Demonstrated ability to provide sound strategic and statistical input on study/research design to meet project needs, regulatory and scientific requirements
• Preferred: Demonstrated ability in presenting results and defending statistical findings, study design and analysis to internal audiences or at external meetings
• Preferred: Demonstrated ability in working within a global team and with CRO partners to ensure operational excellence and efficiencies
• Preferred: Demonstrated effective communication skills (written and oral)