Senior Manager, Statistics

Role Summary

Senior Manager, Statistics. The Rheumatology late development statistics team supports clinical development of phase 2-4 Rheumatology disease assets in the Immunology Therapeutic Area. We offer opportunities for statisticians to apply methodologies and innovations in drug development spanning trial design, monitoring and regulatory submissions, as well as post-marketing access. You will provide statistical leadership to support the research and development organization for assigned projects. Specific areas of work may include clinical trials, patient safety, and global medical affairs.

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). Work independently to implement sound statistical methodology in scientific investigations.
• Represent the function on project team(s) to provide functional area input to asset development. Lead in identifying scientifically 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 the delivery of high-quality outputs according to agreed-upon timelines. Identify and anticipate issues arising in the study design, conduct and propose scientifically sound approaches. Evaluate appropriateness of available software for planned analyses and assess needs for potential development of novel statistical methodology.
• Develop strategy for data presentation and inference. Ensure appropriate interpretation of statistical deliverables in collaboration with other functions. Collaborate in 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. Clearly explain statistical concepts to non-statisticians. Provide responses to questions from clients and pursue analyses suggested by data under supervision.
• Support communications between assigned product team(s) and functional management. Build/drive cross-functional relationships and collaboration.

Qualifications

• MS (8+ years of experience) or PhD (4+ years of experience) in Statistics, Biostatistics, or a highly related field
• Pharmaceutical or related industry knowledge desired, including experience and understanding of drug development and life-cycle management in the regulated environment
• High degree of technical competence
• Ability to identify data or analytical issues, and assist with providing solutions by applying own skills and knowledge or seeking help from others
• Ability to manage project timeline and quality of deliverables
• Effective communication skills, both oral and written
• Ability to build strong relationships with peers and cross-functional partners to achieve higher performance; motivated to drive innovation
• Strong leadership skills and experience in working/managing cross-cultural or overseas teams

Skills

• Statistical analysis, study design, and data interpretation
• Regulatory submission support and lifecycle management
• Collaboration and cross-functional teamwork
• Communication of statistical concepts to non-statisticians
• Proficiency in statistical software and methodologies; evaluating new tools

Education

• MS or PhD in Statistics, Biostatistics, or a related field

Additional Requirements

• None beyond role-specific qualifications; local work location specified (North Chicago, IL or Florham Park, NJ).