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Takeda Pharmaceuticals Senior Manager, Programming in Boston, Massachusetts

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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

  • Contributes to shape the technical direction of automatingstatistical programming deliverables and process improvements by supporting technological innovation and creativity within Takeda SQS.

  • Leads development, implementation and release of global SAS macros& automation tools for key statistical programming activities such as TLFs, submission datasets (SDTM &ADaM) creation; and related derivations.

  • Ensure that software development lifecycle is followed for standards development and appropriate documentation is created and maintained to support GCP compliance.

  • Providessubject matter expertiseon standard domains across all therapeutic areas as needed.

  • Contributes to and/or leads process improvement initiatives.

  • Participates in Data Standards and/or ADaM and/or TLF Governance Board(s) by representing Programming Standards and contribute to review and optimization of corporate standards

  • Collaborate with cross functional teams to create SOPs, Work Instructions and guideline documents on standard tools, processes and methodologies as needed

  • Accountable to manage multiple projects across diverse platforms. Proficiency in other software programming languages such as R, Python, Java etc. is an added advantage.

CORE ELEMENTS RELATED TO THIS ROLE

  • Provides programming leadership and support to clinical study teams, including deployment of programming strategies, standard specifications and templates to comply with regulatory requirements, SOPs and work practices.

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

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

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

  • Leads non-project initiatives across statistical programming

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of technical knowledge)

  • 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 (Vision, strategy and business alignment, people management, communication, influencing others, managing change)

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

  • Excellent communicator, able to conveyboth 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 termsin 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 (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)

  • Recommendsstrategic 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 (The span and nature of one’s engagement with others when performing one’s job, internal and external relationships)

  • 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 (The required level of scientific knowledge, knowledge sharing, innovation and risk taking)

  • Comfortable challengingthe 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 (Products managed, mix of businesses, internal and/or external business environment, cultural considerations)

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

  • Possesses requisite deep expertise ofstatistical 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

  • Providesinput 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.

  • Comprehensive knowledge of technical and regulatory requirements with CDISC submission experience

  • Experienceleading 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.

  • In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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