Sr. Manager, Statistics

Takeda; Cambridge, Northern (MA, KY); Hybrid; USD 137,000 - 215,000; Full time

Benefits offered by this job

Short-term incentives

Long-term incentives

Health insurance

401(k) with company match

Disability insurance

Life insurance

Tuition reimbursement

Paid volunteer time off

Company holidays

Well-being benefits

Sick time & vacation accrual

Job summary

Takeda Development Center Americas, Inc. seeks a Sr. Manager, Statistics to lead statistical design, analysis and reporting for oncology clinical trials, and to represent statistics on global drug development teams.

The role supports regulatory submissions, study protocols, SAPs and CSRs with a focus on quality, timeliness, and cost-effectiveness. The candidate will drive compound-level analysis, supervise statisticians, and stay current with industry advances, while enabling up to 100% remote

Qualifications

• Ph.D. in Mathematics, Biostatistics, Statistics, or related field.
• At least 1 year of related experience in clinical trial statistics.
• Experience with innovative study designs and complex analytical methods.
• Proficiency with SAS, R, Matlab, or similar statistical software.
• Knowledge of FDA/ICH regulations and regulatory submissions.
• Experience overseeing SDTM/ADaM standards and regulatory outputs.

Responsibilities

• Provide statistical support in design, analysis, and interpretation of clinical trials.
• Independently represent statistics on global teams in drug development.
• Develop and review study synopsis, SAPs, CSRs and other regulatory documents.
• Plan and direct compound level analysis and reporting activities with team members.
• Monitor advances in methods and implement innovative approaches.

Skills

Innovative study designs

Complex analytical methods

Inferential statistics

Statistical simulations

Education

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

Tools

SAS

R

Matlab

Job description

Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by Takeda Development Center Americas, Inc. for the following job opportunity:

Job Description

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.

Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue, NW, Room N-5311, Washington, DC 20210.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time