Manager, Statistics

Takeda•Boston, MA

1d•$137,000 - $234,800•Remote

About The Position

Takeda Development Center Americas, Inc. is seeking a 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 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. The estimated salary range reflects an anticipated range for this position. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

Requirements

Ph.D. degree in Mathematics, Biostatistics, Statistics or related field.
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 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