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Associate Director, SQS Programming

Company: Takeda Pharmaceutical
Location: Hoboken
Posted on: May 12, 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 Takeda's 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, Associate 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:

  • Leads statistical programming activities for data anonymization across a compound (or multiple compounds) and related oversight activities ensuring quality and timeliness
  • Sets tasks and prioritization within their compound
  • Successfully engages cross functionally to progress tasks with proven influencing skills
  • Leads process improvement initiatives
  • Existing internal and external presence on varied statistical programming topics
  • Gains experience in Clinical trial data transparency anonymization techniques and Risk assessment scorecard statistical procedures.
  • Gain knowledge of redaction rulesets for various sections based on subjects, disease prevalence or site characteristics.
  • Gain expertise with ICH-GCP guidelines for clinical trial disclosure rules, EudraCT for Data Sharing.
  • Gain expertise in anonymization of patient-level data tables and datasets according to company standard redaction ruleset.
  • Gain proficiency in data privacy requirements for publishing data.CORE ELEMENTS RELATED TO THIS ROLE:
    • Provides technical leadership and ensures adequate statistical programming support for assigned projects
    • Ensure successful implementation of Statistical Programming strategies and efficient execution of the statistical analyses for the assigned clinical projects
    • Applies strong general knowledge of technical and programming methods with applied experience and can mentorship, matrix or direct manage staff
    • Adhere to CDISC (Clinical Data Interchange Standard Consortium) guidelines and best practices
    • Review and create macros for current and future process
    • Contribute to the creation, maintenance, documentation, and validation of standards for outputs and macros
    • Assist in the development of relevant procedures and processes to ensure that statistical programs are properly documented and validated
    • Work on tables reporting and XML upload from SAS - Macros for CT.gov and EudraCT
    • Evaluate the risk of re-identification for clinical trial documents internally.
    • Carry out all activities according to SOPs and Good Clinical Practice (GCP) principles, and ensuring adherence to programming guidelines
    • A desire to learn and educate oneself in best practicces for data anonymization/data sharing.DIMENSIONS AND ASPECTS:Technical/Functional (Line) Expertise
      • Comprehensive understanding of the pharmaceutical industry and statistical programming (e.g., clinical development, the prescription drug distribution process, etc)
      • Participate and engage in external conferences and PHUSE working groups for data transparency efforts and bring back best practices in industry to Takeda to improve existing processes.
      • Technical expertise at the enterprise level, with a broader clinical data life cycle awareness
      • Excellent communication skills and ability to 'translate' across functional linesLeadership -
        • 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 expertiseDecision-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 solutionsInteraction -
            • 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 leadsInnovation -
              • 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 -
                • 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 dataEDUCATION, BEHAVIORAL 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
                  • 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 ProgramsEmpowering Our People to ShineDiscover more at takedajobs.comNo Phone Calls or Recruiters Please.Base Salary Range: $137,200 to $196,000, based on candidate professional experience level. -Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. - -This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. - 8-5-101 et seq.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-SGM -EEO 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 time

Keywords: Takeda Pharmaceutical, Hoboken , Associate Director, SQS Programming, Executive , Hoboken, New Jersey

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