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Job Description

OBJECTIVES/PURPOSE:

Takeda SQS is looking to add individuals to our team that are team oriented, collaborative, strong understanding of the statistical programming function, exceptional leaders and innovators.  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.

To attract and retain the very best talent, we in Takeda SQS are open to flexible or remote working for some roles.  Such roles will have a connection to a Takeda R&D center.

ACCOUNTABILITIES:

• Leads statistical programming activities across multiple studies (or across a compound) and related oversight activities ensuring quality and timeliness

• Contributes to asset level strategies

• Independently completes tasks and prioritization

• Engages cross functionally to progress tasks with proven influencing skills

• Contributes to and/or leads process improvement initiatives

• Exhibits existing internal and external presence on topics of interest

CORE ELEMENTS RELATED TO THIS ROLE:

• Effectively drives and influences project teams towards objectives while enabling and making decisions

• Combines strong general knowledge of technical and programming methods with applied experience to complete tasks and mentor more junior staff

• Leads non-project initiatives across statistical programming

• Demonstrates advanced knowledge of CDISC standards, medical terminology, clinical trial methodologies, and FDA/ICH regulations

• Leads and organizes programming activities for assigned clinical studies and projects

DIMENSIONS AND ASPECTS:

Technical/Functional (Line) Expertise

• Comprehensive understanding of the pharmaceutical industry and statistical programming (e.g., clinical development, the prescription drug distribution process, etc)

• Excellent analytical, technical, and computer skills

• Expert level SAS programming ability and experience with other analytical tools, e.g. R, Python.

• Advanced knowledge of CDISC standards, medical terminology, clinical trial methodologies, and FDA/ICH regulations

Leadership

• Demonstrated ability to work and influence across functions, regions and cultures

• Excellent communicator, able to convey both complex ideas and data, verbally and in writing

• Proven skills as an effective team player who can engender credibility and confidence within the company

• Ability to distill complex technical programming ideas in simple comprehensible terms in order to influence decisions and outcomes

• Embraces and demonstrates a diversity and inclusion mindset

• Leads projects directly or indirectly related to GPTs or other functions

• Independently works and prioritizes projects

• Effectively drives and influences project teams towards objectives while enabling and making decisions

• Contributes to asset level strategies

• Has internal and external presence on topics of interest

Decision-making and Autonomy

• Recommends strategic decisions that impact the statistical programming function

• Accountable for statistical programming decision making within study level

• Participates in initiatives that seek diverse input from multiple constituents and stakeholders to drive innovative solutions

Interaction

• Effectively understands the changing external and internal environment

• Able to effectively implement R&D’s partnership strategy as it applies to statistical programming

• Builds strong relationships and collaborates effectively with other interfacing Takeda functions, including but not limited to statistics, data management, clinical operations, medical directors

Innovation

• Comfortable challenging the status quo and proposing forward thinking innovative solutions

• Implements new ways of working utilizing a wide variety of software (e.g. SAS, R, Python)

• Proposes and embeds ideas around innovative solutions, and leverages new ways to accelerate existing milestones

Complexity

• Able to work in a global ecosystem (internal and external) with a high degree of complexity

• Possesses requisite deep expertise of statistical programming and computing environments  

• Able to see and understand broader, enterprise level perspective and impact to statistical programming

• Exhibits awareness and relevance of best practices related to data sharing

• Provides input regarding standardization and programming of novel data types (including real world evidence, personalized medicine, and wearable devices) as part of a larger digital strategy

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• MS with ~6+ years of industry related experience.

• BS with ~8+ years of industry related experience.

• Experience leading business process transformations and organizational culture change as well as contributing to programming expertise on programs with complex business deliverables

• Operational experience in pharmaceutical drug development with significant direct exposure to clinical development

• Health care business acumen with a comprehensive understanding of the pharmaceutical industry

This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.

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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. 

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U.S. Base Salary Range:

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.

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Job Exempt