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Director, Programming

Company: Takeda Pharmaceutical
Location: White Plains
Posted on: September 16, 2022

Job Description:

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAre 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&Dcenter.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 completionCORE 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 areaDIMENSIONS 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 organizations needs
      • Demonstrate expertise in industry trends and regulatory policy initiatives inclused GcP, CRF 21 Part 11 compliance, and other ICH guidelinesLeadership
        • 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 initiativesDecision-makingand 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 scopeInteraction
            • 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&Ds 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 landscapeInnovation
              • 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 innovationComplexity
                • 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 organizationEDUCATION, 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 industryWHAT 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 ProgramsEmpowering Our People to ShineDiscover more at takedajobs.comNo 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.#LI-SGMEEO StatementTakeda 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.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeby Jobble

Keywords: Takeda Pharmaceutical, White Plains , Director, Programming, Executive , White Plains, New York

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