Senior Manager, Biostatistics

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Job Description

About the role:

The Biostatistics, Senior Manager is responsible for providing statistical support for early and late phase clinical trials in the Oncology 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 Oncology preferred.)
• Strong inter-personal skills.
• Strong project management and time management skills.
  
  
  

As a recognized expert within your business or function, you possess comprehensive expertise in your discipline and broad knowledge across related areas. You excel at anticipating internal/external challenges, recommending improvements, and providing leadership and consultative expertise for a specific business, region or function. Your role involves shaping company policies, solving unique, far-reaching problems affecting operations, disciplines, or other business units/functional areas/regions. You frequently interact with equivalent-level managers and customer representatives, conducting briefings and technical meetings. Operating independently, you provide guidance in the complex situations, lead functional teams or projects, and serve as a best practice/quality resource.

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. Theywork 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.

Delivery & Business Accountabilities

A Senior Manager in Statistics is expected to:

• Lead delivery for one or more assets at study level
• Facilitate execution and delivery collaboration cross functionally, generally within DQS and R&D, and with external vendors
• Enable the consistent execution of the SQS and DQS seamless and predictable delivery mission
• Lead and be accountable for study level delivery strategies being implemented with effective risk identification and mitigation
• Create an internal cross functional and external with vendors sphere of influence in predictable delivery
• Identify opportunity for continuous improvement in delivery approaches and leverages fit-for-purpose mitigations
  
  
  

The Senior Manager in Statistics, through her/his daily work, should have impact on:

• Asset-level GPT strategy and delivery
• Broadly DQS functions
• Parts R&D functions.
  
  
  

Core Elements Related To This Role

• Knowledge of drug development, clinical study design, analysis methodology and data interpretation.
• Knowledge of pharmaceutical industry, overall drug development process with expertise in the cross-functional interfaces with the Statistics function.
• Knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions.
• Provide statistical support for internal decision making, regulatory meetings, submissions and follow up.
• Collaborate/lead in the development of study-level sourcing/vendor strategies and provide oversight of statistical services, ensuring overall quality.
• 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.
• Strong inter-personal skills.
• Strong project management and time management skills.
• Strong collaborative skills and ability to work with a cross-functional team.
  
  
  

Technical/Functional (Line) Expertise

The Senior Manager in Statistics needs to demonstrate:

• Subject matter expertise in several quantitative and statistical areas and establishes oneself as a go-to colleague on a few topics
• Scientific understanding of drug development to inform methodological input with product team or in a platform
• Strong communication skills and ability to translate effectively across functional lines
• Ability to identify and research new innovative approaches and leverage fit-for-purpose methods into programs that he/she is involved in
  
  
  

Leadership

As a Statistician, the Senior Manager may have to:

• Lead one or more studies
• Facilitate collaboration cross functionally and generally within DQS and R&D
• Enable the tactical execution of the SQS and DQS vision and mission
• Lead and be accountable for study level strategies being implemented
  
  
  

Education

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

• PHD with ~ 3 years experience
• MS with ~ 6 years experience
  
  
  

Behavioural Competencies

An ideal candidate for this position should:

• Inspire teamwork
• Assess benefit risk of options
• Develop understanding of business beyond SQS
• Focuses on priorities
  
  
  

Takeda Compensation And Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Boston, MA

U.S. Base Salary Range

$137,000.00 - $215,270.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-termincentives. 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.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

LocationsBoston, MA

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time

Job Exempt

Yes

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