Senior Manager, Statistics

Objectives:

Takeda is a global, values-based, R&D-driven, top 15 biopharmaceutical leader committed todiscoveranddeliverlife-transforming treatments, guided by our commitment to patients, ourpeopleand 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 tospeedthe development of highly innovative treatments to patients. These scientists (from quantitative clinical pharmacology, statistics, programming, outcomes research and epidemiology, patient safety & pharmacovigilance) bring theirexpertiseto 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 areteam oriented, collaborative, strong understanding of the statistics function, exceptionalleadersand innovators. SQS aspires to bring safe and effective medications tothe patientswith 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,Statisticsis responsible forproviding 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, leadingdata 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 tooptimizeclinical trial designs.

• Implement a quantitativedecision makingframework to support data-driven decisions in clinical development

• Participate in preparation of regulatory submissions and responses to regulatory agencies.

• Contribute to asset level strategies toidentifyand mitigate delivery risks.

• A Senior Manager, Statistics, through her/his daily work, should haveimpacton:

• 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,analysismethodologyand data interpretation.

• Advanced knowledge of pharmaceutical industry, overall drug developmentprocessandexpertiseinthe cross-functional interfaces with thestatisticsfunction.

• Advanced knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinicaltrialsand regulatory submissions.

• Strong statistical programming skills (SAS and R)

• Excellent oral and writtencommunicationsskills.

• Specialized statisticalexpertisein 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 projectobjectives.

Technical/Functional Expertise: 

A Senior Manager, Statistics needs todemonstrate:

• The capability to gain broader technicalexpertiseoutside 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 methodsand alsofor continuous improvement through various avenues of the organization

Leadership:

A Senior Manager, Statistics may have to:

• Lead projects directly or indirectly related to Global Program Teams (GPTs) or other functions

• Work independently and prioritize projects

• Effectively drive and influence project teams towardsobjectiveswhile enabling and making decisions

• Contribute to asset level strategies

• Have internal and external presence on topics of interest

Educations:  

Applicants for this position should havedegreein statistics/biostatistics or in other equivalent quantitative sciences along with the following specific credentials:

• PhD with approximately 3+ years of experience.

• MS with approximately 6+ years of experience.

Behavioral Competencies:

An ideal candidate for this position should:

• Be able to make decisions

• Initiate and foster collaborative relationships