Sr. Director, Statistics

Takeda•Boston, MA

10d

About The Position

Objective / Purpose: Takeda’s mission is to serve patients. This patient focus drives the organization to create the medicines patients need and the innovations that will deliver genuine improvements to their lives. Takeda insists on a high standard for innovation in order to deliver true value to patients, healthcare providers, payers and other stakeholders. The R&D Data and Quantitative Sciences organization influences senior leadership and stakeholders to advance Takeda’s R&D pipeline. Central to Takeda’s R&D operating model are the pillars of Data & Quantitative Sciences, which are leveraged to support the imperative of becoming a data-driven and scientifically and quantitatively disciplined rigorous organization. This focus enhances the speed and success of R&D growth and strengthens competitiveness. R&D Data & Quantitative Sciences encompasses several global functions, including Quantitative Pharmacology and Translational Sciences, Statistics & Quantitative Sciences, Programming, Global Evidence Outcomes, Patient Safety & Pharmacovigilance, and Strategic Operations The department integrates data science, analytics, and quantitative methods to enhance efficiency and precision throughout the drug discovery and development lifecycle. It leverages cutting-edge technology, machine learning, AI, and statistical methods to analyze complex datasets, generate predictive models, and provide actionable insights. It collaborates cross-functionally to ensure scientific rigor and compliance with regulatory standards in all decision-making processes.

Requirements

Desired education qualifications and equivalencies (e.g., 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

Responsibilities

Play key role in execution and delivery leadership of Therapeutic Area Unit (TAU), Business Unit (BU), or SQS function or specialty area in preclinical / clinical / translational
Be the cross functional leader and accountable execution and delivery decision maker that has direct impact on R&D
Define and contribute to execution and delivery strategic mission and the respective implementation for the promotion of R&D seamless and predictable delivery
Proactively identify risks and mitigation strategies to optimize R&D business impact in terms of costs, quality, and timeliness
Be accountable for growth and development of SQS delivery capabilities through processes, systems and oversight mechanisms
Show influential execution and delivery leadership both within and outside of Takeda with vendors and partners
Provide strategic vision for long-term delivery innovation

Benefits

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

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