JOB LOCATION: Cambridge, MA

POSITION: Sr. Manager, Statistics

POSITION DESCRIPTION: 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.

The estimated salary range reflects an anticipated range for this position. The actual base salary offered will be in accordance w/ state or local min wage requirements for the job location.

US based employees may be eligible for short-term &/or long-term incentives. US based employees may be eligible to participate in medical, dental, vision insurance, 401(k) plan & company match, short-term & long-term disability coverage, basic life insurance, tuition reimbursement program, paid volunteer time off, company holidays, & well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, & new hires are eligible to accrue up to 120 hours of paid vacation.

REQUIREMENTS: Ph.D. in Mathematics, Biostatistics, Statistics, or related field, plus 1 year of related experience. Prior experience must include: 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.

Full time. $137,000 - $215,270 per year.



Locations
Boston, MA

Worker Type
Employee

Worker Sub-Type
Regular

Time Type
Full time