Manager, Statistics

Role Summary

Manager, Statistics at Takeda Development Center Americas, Inc. Location: Cambridge, MA (Boston, MA listed). Up to 100% remote work allowed from anywhere in the U.S. This role provides statistical support in the design, analysis, and interpretation of clinical trials to enable quantitative decision making at the compound level; independently represents the statistics function on global teams in support of drug development; and leads the development and review of the study synopsis, protocol, statistical analysis plan, clinical study report, and other regulatory submission documents to ensure accurate and statistically valid deliverables.

Responsibilities

• Provide statistical support in the design, analysis, and interpretation of clinical trials to enable quantitative decision making at the compound level.
• Independently represent the statistics function on global teams in support of drug development.
• Develop and review the study synopsis, protocol, statistical analysis plan, clinical study report, and other regulatory submission documents, ensuring accurate and statistically valid deliverables.
• Leverage internal and external resources to achieve quality, timely, and cost-effective compound-level and submission deliverables.
• Plan and direct compound-level analysis and reporting activities including work of other statisticians and programmers.
• Monitor and contribute to industry advances in statistical methods to optimize study designs and statistical analysis methods, and implement innovative approaches at a compound level.

Qualifications

• Ph.D. degree in Mathematics, Biostatistics, Statistics or related field.
• Experience with innovative clinical study designs, complex analytical methods, and inferential statistics; ability to conduct mathematical and statistical simulations based on advanced methodologies to support clinical trials.
• Hands-on experience with data analyses utilizing statistical programming software and languages (such as SAS, R, MATLAB, etc.) to facilitate drug development processes in the pharmaceutical industry.
• Extensive knowledge of FDA and ICH regulations and industry standards applicable to the design, conduct and analysis of clinical trials, and regulatory submissions.
• Provide oversight of statistical activities (such as SDTM/ADaM standards, TFLs, etc.) to ensure timeline and quality of analysis data and statistical outputs.