Takeda · 1 day ago
Senior Director - Statistics
Takeda is a biopharmaceutical company focused on delivering transformative therapies to patients. The Senior Director Biostatistics leads and manages a team of biostatisticians and data scientists, developing statistical strategies to drive innovation in drug development while ensuring compliance with regulatory guidelines.
Responsibilities
Lead, mentor, and manage a group supporting translational and exploratory statistical analyses across Therapeutic Area Units (TAUs)
Drive collaborations with biomarker, translational, and clinical scientists to enable biomarker development strategies
Strategize and prioritize opportunities for AI/ML, RWE, advanced analytics, and modeling within the Quantitative Sciences group
Oversee and ensure achievement of all deliverables and milestones for programs across TAUs
Manage, mentor, and grow an interdisciplinary team of biostatisticians, computational scientists, and data scientists
Develop and manage relationships with the external research community and represent the organization at professional forums
Provide statistical leadership in the development and review of study protocols, analysis plans, and regulatory submission documents
Qualification
Required
PhD degree in a scientific discipline with 12+ years' experience, or MS with 15+ years' experience
Experience with at least one NDA/CTDs or other regulatory submissions
Experience representing Statistics function in interactions with regulatory agencies
Advanced knowledge of clinical study designs, analysis methodology and data interpretation
Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in the cross-functional interfaces with the Statistics function
Advanced knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions
Strong statistical programming skills
Excellent oral and written communications skills
Specialized statistical expertise in multiple therapeutic areas or development phases
Strong interpersonal and people management skills
Strong project management skills
Strong collaborative skills and ability to work with a cross-functional team
Ability to inspire and motivate staff
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Recent News
Pharmaceutical Technology
2026-01-11
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