Senior Manager, Statistics

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Job Description

OBJECTIVES/PURPOSE: 

Takeda is a global, values-based, R&D-driven, top 10 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 (DQS) is made up of more than 250 quantitative scientists who harness the insight of data and digital to speed the development of highly innovative treatments to patients. These scientists (from statistics, programming, outcomes research and epidemiology, and quantitative clinical pharmacology,) bring their expertise to our global program teams and re-imagine 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: 
The Biostatistics, Senior Manager is responsible for providing statistical support for early and late phase clinical trials in the GI & Inflammation (GI2) Therapeutic Area statistics group and timely delivery of statistical deliverables. This role contributes to Takeda's mission. 
 
How you will contribute: 

• Design clinical trials, provide strategic inputs and innovative solutions, and support the team to make data-driven quantitative decisions

• Conduct advanced statistical analysis and ensure robust and accurate data analysis through extensive knowledge in biostatistics  

• Support the adoption of novel designs and innovative statistical methods  

• Facilitate execution and delivery collaboration with cross-functional teams to achieve project objectives 

• Lead and be accountable for study level delivery strategies being implemented with effective risk identification and mitigation 

Skills and qualifications:  

• Knowledge of drug development, clinical study design, trial simulations, analysis methodology and data interpretation.  

• Innovative thinker, driving the adoption of novel design, innovative statistical methods and complex modeling. 

• Knowledge of FDA and ICH regulations and industry standards applicable to study design, data analysis of clinical trials and regulatory submissions. 

• Statistical leadership and support for quantitative decision making, regulatory meetings, and submissions. 

• Strong collaborative skills and ability to effectively work with a cross-functional team to achieve project objectives. 

• Strong statistical programming skills (SAS and/or R). 

• Excellent oral and written communications skills. 

• Specialized statistical expertise in multiple therapeutic areas or clinical trial development phases. (Experience in GI and/or immunology preferred.) 

• Strong inter-personal skills. 

• Strong project management and time management skills. 

  
As a recognized expert within your business or function, you possess comprehensive