Sr. Manager, Statistics

Takeda Development Center Americas, Inc. is seeking a candidate for the following opportunity in Cambridge, MA. Up to 100% remote work allowed from anywhere in the U.S.

About the role

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 the 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 the 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.

Responsibilities

• Provide statistical support for clinical trials, including design, analysis, and interpretation.
• Represent the statistics function on global drug development teams.
• Develop and review key documents such as study synopses, protocols, statistical analysis plans, and clinical study reports.
• Ensure deliverables are statistically valid and meet regulatory standards.
• Plan and oversee compound-level analysis and reporting activities.
• Monitor industry advances in statistical methods and implement innovative approaches.
• Oversee statistical activities (e.g., SDTM/ADaM standards, TFLs) to ensure timeline and quality of analysis data and outputs.

Requirements

• Ph.D. in Mathematics, Biostatistics, Statistics, or a related field, plus 1 year of related experience.
• Experience with innovative clinical study designs, complex analytical methods, and inferential statistics.
• Ability to conduct mathematical and statistical simulations to support clinical trials.
• Proficiency in mathematical and statistical programming software and languages (e.g., SAS, R, Matlab).
• Extensive knowledge of FDA and ICH regulations and industry standards for clinical trials and regulatory submissions.

Benefits

• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Short-term and long-term disability coverage.
• Basic life insurance.
• Tuition reimbursement program.
• Paid volunteer time off.
• Company holidays.
• Well-being benefits.
• Up to 80 hours of sick time per calendar year.
• New hires eligible to accrue up to 120 hours of paid vacation.
• Eligibility for short-term and long-term incentives.

Pay

$137,000 - $215,270 per year. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

Schedule

Full time.