Senior Manager, Statistics; Oncology

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Objectives:

Takeda is a global, values-based, R&D-driven, top 15 biopharmaceutical leader committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet.

Our Data and Quantitative Sciences group (DQS) is made up of more than 500 quantitative scientists who harness the insight of data and digital to speed the development of highly innovative treatments to patients. These scientists (from quantitative clinical pharmacology, statistics, programming, outcomes research and epidemiology, patient safety & pharmacovigilance) bring their expertise to our global program teams and reimagine our disciplines.

They work with novel data streams, including real-world data and digital tools, and apply advanced analytics including artificial intelligence and automation.

As part of DQS, the Statistics and Quantitative Sciences (SQS) at Takeda is looking to add individuals to our team that are team oriented, collaborative, strong understanding of the statistics function, exceptional leaders and innovators. SQS aspires to bring safe and effective medications to the patients with our quantitative skills. We design efficient trials, contribute to clinical development strategies, perform high quality statistical analyses, and pursue operational excellence.

About the role:

This Senior Manager, Statistics is responsible for providing statistical support in clinical development related to diseases and assets within the Neuroscience Therapeutic Area. This role involves independently managing projects, providing innovative solutions to problems, leading data strategy development. This role contributes to Takeda’s mission.

Delivery and Business Accountabilities:

• Lead and be accountable for study/program level delivery
• Effectively drive and influence project teams towards seamless delivery while enabling and making decisions
• Conduct advanced statistical analyses and perform trial simulations to provide innovative solutions and to optimize clinical trial designs.
• Implement a quantitative decision making framework to support data-driven decisions in clinical development
• Participate in preparation of regulatory submissions and responses to regulatory agencies.
• Contribute to asset level strategies to identify and mitigate delivery risks.
• A Senior Manager, Statistics, through her/his daily work, should have impact on:
• Global project sub-teams (e.g., Evidence Generation)
• Broadly DQS functions
• Parts R&D functions

Core Skill and Qualification Elements:

• Advanced knowledge of drug development, clinical study designs, trial simulations, analysis methodology and data interpretation.
• Advanced knowledge of pharmaceutical industry, overall drug development process and 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 (SAS and R)
• Excellent oral and written communications skills.
• Specialized statistical expertise in multiple therapeutic areas or clinical trial development phases (Experience in Neuroscience preferred).
• Strong project management skills.
• Strong collaborative skills and ability to work with a cross-functional team to achieve project objectives.

Technical/Functional Expertise:

A Senior Manager, Statistics needs to demonstrate:

• The capability to gain broader technical expertise outside of primary area
• The ability to communicate effectively with cross functional teams and explain statistical and quantitative concepts to non-experts
• The drive for learning techniques and methods and also for continuous improvement through various avenues of the organization

Leadership:

A Senior Manager, Statistics may have to:

• Lead projects…