Senior Manager, Statistics - Hybrid

Role Summary

The Senior Manager, Statistics provides statistical leadership to support the research and development organization for assigned projects, with involvement in clinical trials, patient safety, and global medical affairs. The role requires independent collaboration with experts across disciplines to advance medicines to patients.

Responsibilities

• Support regulatory submission and product life-cycle management strategy planning and implementation. Provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs. Independently develop protocols and statistical analysis plans (or product safety analysis plans/integrated summary of safety analysis plans/analysis plans for GMA evidence generation). Implement sound statistical methodology in scientific investigations.
• Represent the function on project teams to provide input to asset development. Identify appropriate data collection instruments. Provide programming specifications for derived variables and analysis datasets. Guide Data Science and other functions in preparing for database lock. Ensure accuracy of data released for statistical analysis.
• Independently perform statistical analyses as per the analysis plan. Collaborate with Statistical Programming to ensure high-quality outputs within timelines. Identify issues in study design and conduct; propose scientifically sound approaches. Evaluate software for planned analyses and consider need for novel statistical methodology.
• Develop strategy for data presentation and inference. Ensure appropriate interpretation of statistical deliverables in collaboration with other functions. Collaborate on publication of scientific research. Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures.
• Work collaboratively with multifunction teams per agreed timelines. Explain statistical concepts to non-statisticians. Respond to client questions and pursue analyses suggested by data under supervision.
• Support communications between assigned product teams and functional management. Build and drive cross-functional relationships and collaboration.

Qualifications

• MS (with 8+ years of experience) or PhD (with 4+ years of experience) in Statistics, Biostatistics, or a closely related field.
• High degree of technical competence and effective oral and written communication.
• Ability to identify data or analytical issues and propose solutions using own skills or collaboration.
• Ability to manage project timelines and deliverable quality.
• Ability to build strong relationships with peers and cross-functional partners; motivated to drive innovation.
• Strong leadership skills and experience managing cross-cultural or overseas teams.
• Pharmaceutical or related industry knowledge, including drug development and lifecycle management in a regulated environment (preferred).