Senior Statistics Leader - Clinical Trials (Remote)

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

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