Sr. Manager, Statistics

3316 Takeda Development Center Americas•Boston, MA

2d•Remote

About The Position

Takeda Development Center Americas, Inc. is seeking a Sr. Manager, Statistics with the following duties: provide statistical support in the design, analysis, and interpretation of clinical trials to enable quantitative decision-making at a compound level for Takeda oncology programs; independently represent 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. Up to 100% remote work allowed from anywhere in the U.S.

Requirements

Ph.D. in Mathematics, Biostatistics, Statistics, or related field, plus 1 year of related experience.
Familiarize with innovative clinical study designs, complex analytical methods, and inferential statistics and be able to conduct mathematical and statistical simulations based on those advanced methodologies to support clinical trials.
Apply advanced knowledge and leverage hands-on experience on data analyses utilizing mathematical and statistical programming software and languages (such as SAS, R, Matlab, etc.) to facilitate drug development processes in pharmaceutical industry.
Demonstrate 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.

Responsibilities

Provide statistical support in the design, analysis, and interpretation of clinical trials to enable quantitative decision-making at a compound level for Takeda oncology programs.
Independently represent 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.