Senior Biostatistics Manager, Biosimilars

This is a fully remote position, open to applicants in United States.

📋 Description

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

• Implements, supervises, and supports standards, technical quality, and consistent methodologies 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, and other essential study-related documentation, protocol deviations, Flash Memos, Clinical Study Reports (CSRs), and additional communications in close collaboration with CROs within a full-service CRO model.

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

• Supervises statistical work carried out by CROs in a full-service CRO model.

• Conducts statistical analyses of multiple studies/projects and subsequent exploratory analyses, and offers sound conclusions and recommendations.

• Represents the Biostatistics function and participates in multidisciplinary project team meetings; collaborates closely with other functional team members; incorporates knowledge from cross-functional areas to provide effective statistical guidance to teams.

• Proactively identifies and communicates resource and quality issues that may affect deliverables or timelines within the functional area and across functions.

• Remains informed about the latest developments in the field of statistics in drug development and contributes to scientific progress by publishing applied research in scientific journals and books and presenting statistical methodologies at internal or external scientific meetings.

• Engages in the review of CRO Policies, SOPs, and the development of other controlled documents and in the development and review of Amgen-CRO’s process maps; contributes to process improvement and operational efficiency.

• Complies with all Amgen Policies, Standard Operating Procedures (SOPs), and other applicable standards related 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 a related field with substantial statistical content, and 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research; or Doctoral degree in Statistics/Biostatistics or a related field with substantial statistical content, and 5 years of post-graduate statistical experience in the pharmaceutical industry or medical research.

• Knowledge and experience in the development of biosimilars, non-inferiority, or equivalence trials.

• Statistical contributions to regulatory submissions.

• Experience in statistical methodologies associated with 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.

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

• Proven ability to provide strategic and statistical insights on study/research design to fulfill project requirements, regulatory expectations, and scientific standards.

• Demonstrated proficiency in presenting results and defending statistical findings, study design, and analysis, whether to internal teams (study/product team) or at external meetings such as investigator meetings, steering committee meetings, advisory board meetings, or regulatory meetings.

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

• Excellent communication skills, both written and verbal.

🏝️ Benefits

• A comprehensive employee benefits package, which 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, or for field sales representatives, a sales-based incentive plan.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models where possible.