Associate Director, Programming at Takeda Development Center Americas, Inc.

Posted in General Business 13 days ago.

Type: Full-Time
Location: Boston, Massachusetts





Job Description:

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Job Description

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


  • Provides technical leadership and ensures adequate statistical programming support for assigned projects.

  • Leads and implements aggregate level statistical programming activities for registrational studies (e.g., ISS, ISE and other pooled analyses supporting regulatory submissions).

  • Leads statistical programming activities in regulatory submissions space across a compound (or multiple compounds) and provide related oversight ensuring quality and timeliness

  • Leads activities to guide/create/review electronic submission package for health authorities.

  • Leads proactivie and effective communications with stakeholders and collaborators to initiate statistical programming activities in the regulatory submission space with strategic thinking to build efficient processes to support activities.

  • Sets tasks, prioritization, and effective resourcing plans within their projects.

  • Leads process improvement initiatives

  • Existing internal and external presence on varied statistical programming topics

CORE ELEMENTS RELATED TO THIS ROLE


  • Provides technical leadership and ensures adequate statistical programming support for aggregated level data analyses across a compound (or compounds) (e.g., ISS, ISE)

  • Strong knowledge on regulatory submission requirements and technologies, including eCTD components for statistical programming deliverables.

  • Strong experiences to prepare electronic submissions package to regulatory agencies (e.g., FDA, PMDA) and be able to learn and implement new requirements.

  • Reports directory to Head, Statistical Programming Center of Excellence (CoE) and assists to ensure successful and effective implementation of statistical programming strategies for regulatory submissions and efficient execution of CDISC data implementations including Pinnacle 21 executions and submission ready define.xml creations.

  • Applies strong general knowledge of technical and programming methods with applied experience and can mentorship, matrix or direct manage staff.

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)

  • Technical expertise at the enterprise level, with a broader clinical data life cycle awareness

  • Technical expertise in statistical programming deliverables and requirement in regulatory submission space.

  • Understanding the current processes and come up with standardize processes to make processes more efficient

  • Excellent communication skills and ability to ‘translate’ across functional lines

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)

  • Technical expertise at the enterprise level, with a broader clinical data life cycle awareness

  • Technical expertise in statistical programming deliverables and requirement in regulatory submission space.

  • Understanding the current processes and come up with standardize processes to make processes more efficient

  • Excellent communication skills and ability to ‘translate’ across functional lines

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 persuasively convey both ideas and data, verbally and in writing

  • Functional level leadership with the ability to inspire, motivate and drive results

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

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

  • Leads one or more assets at GPT level

  • Facilitates collaboration cross functionally in GPTs and generally within DSI and R&D

  • Enables the tactical execution of the SQS and DSI vision and mission

  • Leads and accountable for asset level strategies being implemented

  • Mentorship, matrix, or direct management of small team of SQS colleagues

  • Creates an internal and external sphere of influence in area of expertise

Decision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)



  • Ability to make strategic decisions that impact the statistical programming function

  • Accountable for statistical programming decision making within their compound

  • Participate in and/or lead 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 navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace

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

  • Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions, including but not limited to statistics, data management, clinical operations, medical directors, global program leads

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


  • Forward thinking with the ability to recommend, influence and implement continuous innovation

  • Challenge the status quo and propose forward thinking innovative solutions

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

  • Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.

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


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

  • Deep expertise required across statistical programming and computing environments 

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

  • Ability to input into best practices with data sharing


  • Ability to input into programming and standardization for novel data such as real-world data, digital data, wearable device data

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:  (List the essential and desirable education and competency requirements to perform the primary responsibilities of the job.  Any minimum requirements should be noted.)


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

  • BS with ~10+ years of industry related experience.

  • Proven track record of leading business process transformations and organizational culture change as well as driving 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

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 persuasively convey both ideas and data, verbally and in writing

  • Functional level leadership with the ability to inspire, motivate and drive results

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

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

  • Leads one or more assets at GPT level

  • Facilitates collaboration cross functionally in GPTs and generally within DSI and R&D

  • Enables the tactical execution of the SQS and DSI vision and mission

  • Leads and accountable for asset level strategies being implemented

  • Mentorship, matrix, or direct management of small team of SQS colleagues

  • Creates an internal and external sphere of influence in area of expertise

Decision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)



  • Ability to make strategic decisions that impact the statistical programming function

  • Accountable for statistical programming decision making within their compound

WHAT TAKEDA CAN OFFER YOU:


  • 401(k) with company match and Annual Retirement Contribution Plan

  • Tuition reimbursement Company match of charitable contributions

  • Health & Wellness programs including onsite flu shots and health screenings

  • Generous time off for vacation and the option to purchase additional vacation days

  • Community Outreach Programs

Empowering Our People to Shine

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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