Senior Biostatistics Manager, Biosimilars

This is a fully remote position, open to applicants in District of Columbia, +1 more state.

📋 Description

• Oversee a significant product, as well as more intricate studies and projects.

• Ensure that all statistical documentation related to clinical activities adheres to required standards and is statistically accurate.

• Influence and play a key role in the development strategy, defending statistical methodologies both internally and externally.

• Implement, manage, and support standards, technical quality, and consistent methodologies in strategy, study design, and statistical analysis.

• Plan and execute statistical contributions to protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph (TLG) shells, Submission Data File (SDF) specifications, and other essential study-related documentation, protocol deviations, Flash Memos, Clinical Study Reports (CSRs), and relevant communications in close collaboration with CROs under a full-service CRO model.

• Provide statistical insights for clinical publications, Clinical Summary of Safety (CSSs), Clinical Summary of Efficacy (CSEs), Clinical Overviews (COs), and regulatory documents.

• Supervise statistical work conducted by CROs within a full-service CRO model.

• Conduct statistical analyses of multiple studies/projects along with subsequent exploratory analyses, drawing sound conclusions and recommendations.

• Represent the Biostatistics function and engage in multidisciplinary project team meetings; collaborate effectively with other functional team members; utilize knowledge of cross-functional areas to provide solid statistical guidance to teams (e.g., offer support and input on case report form design and data collection).

• Proactively identify and communicate resource and quality concerns that may affect deliverables or timelines both within the functional area and cross-functionally.

• Be knowledgeable about statistical policies and strategies at Amgen; possess a working understanding of theoretical and applied statistics, as well as regulatory guidelines and industry practices regarding biosimilar development.

• Stay updated on the latest advancements in statistics within drug development and contribute to scientific progress by publishing applied research in academic journals and books, and presenting statistical methodologies at both internal and external scientific meetings.

• Participate in reviewing CRO policies, SOPs, and other controlled document development, and in developing and reviewing Amgen-CRO’s process maps; contribute to process enhancements and operational efficiency.

• Comply with all Amgen policies, standard operating procedures (SOPs), and other relevant standards applicable to biosimilar development.

⛳️ Requirements

• Doctorate degree with 2 years of Biostatistics experience, or Master's degree with 6 years of Biostatistics experience, or Bachelor's degree with 8 years of Biostatistics experience.

• Master's degree in Statistics/Biostatistics or another field with significant statistical content, along with 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research; or a Doctoral degree in Statistics/Biostatistics or a related field, with 5 years of post-graduate statistical experience in the same domains.

• Knowledge and experience in biosimilar development, non-inferiority, or equivalence trials.

• Statistical contributions to regulatory submissions.

• Experience in statistical methodologies related to adaptive designs (e.g., group sequential design, adaptations for treatment arm selection design, Bayesian adaptive design), and/or combined Phase 1/2 or Phase 2/3 designs.

• Independent leadership in the design, analysis, and reporting of at least one complex study or multiple less complex studies/projects within the Pharmaceutical, Biotechnology, or Public Health settings in Industry, Government, or Academia.

• Proven capability to provide strategic and statistical input on study/research design to fulfill project requirements, regulatory, and scientific obligations.

• Demonstrated ability to present results and defend statistical findings, study design, and analysis, whether to internal audiences (study/product team) or at external gatherings such as investigator meetings, steering committee meetings, advisory board meetings, or regulatory meetings.

• Proven experience working within a global team and with CRO partners to ensure operational excellence and efficiency.

• Effective communication skills, both written and oral.

🏝️ Benefits

• A comprehensive employee benefits package that includes a Retirement and Savings Plan with generous company contributions.

• Group medical, dental, and vision coverage.

• Life and disability insurance.

• Flexible spending accounts.

• A discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models where feasible.