Director, Programming

Company: Takeda Pharmaceutical
Location: Newark
Posted on: May 13, 2022

Job Description:

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Job Description
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Statistical Programming, Director.

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.

POSITION OBJECTIVES:
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.

POSITION ACCOUNTABILITIES:
Develops and executes strategic plan related to training for all SQS Programming staff and partnered vendors to meet the needs of the business and ensure GcP compliance
Develops and executes training and education strategy for new statistical software and technology platforms in partnership with leadership from Chief Statistical Office, Technology and Operations
Evaluates industry trends and best practices with respect to cutting-edge tools and novel programming approaches that leverage machine learning, AI, and metadata driven processes to determine organizational fit
Leads development strategy and writing of programming processes and associated documentation
Develops expertise in all SQS processes to support and ensure inspection readiness
Interface with cross-functional subject matter experts and quality organization in preparation for audit and inspection planning, implementation and follow-up
Leads strategic discussions, ownership, maintenance and content collaboration for department website and related document repositories
Successfully engages cross-functionally to progress tasks with proven influencing skills
Leads process improvement initiatives to successful completion

CORE ELEMENTS RELATED TO THIS ROLE:
Solid project management, leadership and problem-solving skills with the ability to execute on plans with limited direction and support
Proven conceptual thinking and strategic problem-solving ability
Ability to prioritize and lead various team members at various levels to achieve goals
Ability to write detailed procedure and policy documents based upon discussions with process owners and in compliance with technical writing standards and to provide mentoring in this area for others in the organization
Excellent people management skills
Proven ability to distill technical jargon and communicate effectively
Well developed expertise in strategic and analytical thinking
Demonstrated flexibility to adjust to a broad range of responsibilities
Solid knowledge and experiences with GCP regulatory inspections
Proven ability to adapt to change and manage cultural change in an evolving environment.
Demonstrated initiative in staying abreast on current industry topics as they relate to functional area

DIMENSIONS AND ASPECTS:
Technical/Functional (Line) Expertise
Possess a comprehensive understanding of the pharmaceutical industry and statistical programming ecosystem (e.g., clinical development, the prescription drug distribution process, etc)
Possess technical expertise at the enterprise level and specifically related to technical writing standards
Capable of leading cross-functional teams addressing a wide variety of the organization's needs
Demonstrate expertise in industry trends and regulatory policy initiatives inclused GcP, CRF 21 Part 11 compliance, and other ICH guidelines

Leadership
Ability to partner with colleagues and leadership to understand process needs and gaps
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
Cross functional leader and influential decision maker that has direct impact on assets and functions
Key decision maker in training strategies and enabling tactical implementation
Proactively creates and implements sub-strategies to enable the promotion of SQS and DSI vision and mission within TAUs, BUs, and R&D functions
Mentorship, matrix or direct management of - team supporting SQS operations
Leader both within and outside of Takeda in area of expertise for organizational initiatives

Decision-making -and Autonomy
Provide input to highly complex decisions that impact the statistical programming function
Accountable for decision making for the statistical programming function
Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions
Ability to incorporate feedback and ensure decisions are implemented swiftly to yield flawless execution
Accountable for providing input to and implementing vision and strategy for designated scope

Interaction
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 and statistics
Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions, including but not limited to statistics, data management, information technology, clinical operations, regulatory, and the data sciences organization
Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise.
Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner
Demonstrates flexibility in an ever evolving landscape

Innovation
Forward thinking with the ability to recommend, influence and implement organizational change and continuous innovation
Challenge the status quo and propose forward thinking innovative solutions
Ability to take risks implementing innovative solutions, accelerating time to market
Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.
Models respect and inclusion in all interactions, creating a culture that fosters innovation

Complexity
Ability to work in a global ecosystem (internal and external) with a high degree of complexity
Ability to see and understand broader, enterprise level perspective - and understand -and assess impact to statistics organization

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
BA/BS in data science, statistics or a related field with minimum of 10 years of relevant experience in pharmaceutical industry. MA/MS/MBA a plus..
Demonstrated knowledge of clinical research with emphasis on statistics and statistical programming
Intermediate level proficiency in SAS, R, Python or other programming language.
Understanding of CDISC standards and associated submission requirements
Experience in developing training plans and curriculum
Experience with building, planning and executing training and educational courses
In-depth understanding of compliance risks facing the pharmaceutical industry with a particular focus on issues facing the clinical organization
Experience in problem solving, negotiations, and collaborative team building with non-direct reports and other stakeholders
Experience in writing technical documentation and standard operating procedures
Experience in managing projects towards process improvements
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

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

Discover more at takedajobs.com

No Phone Calls or Recruiters Please.

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

Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.

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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

Keywords: Takeda Pharmaceutical, Newark , Director, Programming, Executive , Newark, New Jersey