Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director, Programming in our Cambridge, MA office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
Leads a team of programmers working on standard macro development across therapeutic areas and implements strategies to build efficient processes and resourcing plans
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.
Develops standard programs and macros to support efficient cross TA programming development efforts and ensure quality and timeliness
Sets tasks and prioritization of activities within the projects
Successfully engages cross functionally to progress tasks with proven influencing skills
Leads process improvement initiatives
Holds existing internal and external presence on varied statistical programming topics
Mentors and educates to promote latest trends in clinical development space
Aligns the team efforts with the company goals and takes initiative to meet them
Contributes to process improvements by supporting technological innovation and creativity within Takeda SQS
CORE ELEMENTS RELATED TO THIS ROLE
Provides technical leadership and ensures adequate statistical programming support for assigned projects
Leads and organizes programming activities for assigned standard program development projects
Assists automation/ standard group lead to ensure successful implementation of standard programming strategies and efficient execution of assigned projects
Applies proven technical and programming methods with applied experience to develop standard macros, tools, utilities and projects
Strong communication and writing skills to lead team discussions and documentation
Proactively evaluate and manage resource demand and allocation to meet current and future business needs ensuring effective utilization of resources and maintenance of functional planning systems
Assist in review and development of common data model (CDM), SDTM/ADaM specifications and reporting macros
Mentor and lead as needed to educate and promote latest trends in clinical development space
Technical/Functional (Line) Expertise
Comprehensive understanding of the pharmaceutical industry and statistical programming (e.g., clinical development, the prescription drug distribution process, etc)
Should have Advanced knowledge of CDISC standards, medical terminology, clinical trial methodologies, and FDA/ICH regulations
Technical expertise at the enterprise level, with a broader clinical data life cycle awareness
Excellent communication skills and ability to 'translate' across functional lines
In-depth knowledge of CDISC standards is required
Should have contributed to standards development (i.e SDTM, ADaM, TFL's, utilities etc.)
Multiple skill sets comprising of exposure to various programming languages like R, Python, etc. would be preferred
Should be motivated to learn new technologies and cater to business needs
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
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
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
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.
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:
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
Project leadership 5+ years of industry experience.
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.
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.