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Senior Manager, Programming

Company: Takeda Pharmaceutical
Location: Elizabeth
Posted on: November 20, 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 Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.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

  • Create data cleaning reporting solutions with appropriate oversight that support the quality and timely delivery of data cleaning, study status metric, and monitoring reports and visualizations required per standard and study specific data review plans.
  • Create any needed documentation for reports throughout the lifespan of the study and/or asset for all deliverables
  • Complies with applicable SOPs and work practices
  • Serves as a technical resource to the study teams for data visualization and reporting tools
  • Collaborates with other analysts, Clinical Data Managers, and other roles as needed to apply standards and develop data cleaning reports to support of the data review plan
  • Supports knowledge development of others on reporting tools that support the accuracy and integrity of study data CORE ELEMENTS RELATED TO THIS ROLE
    • Provide programming expertise for data cleaning to efficiently ensure high quality data
    • Works with Clinical Data Standards and Clinical Data Management teams in the development of data cleaning/quality checks, study status metric, and monitoring reports standards.
    • Enhances available reporting tools/macros or creates new ones to support the review of clinical trial data and trial status information for cross-functional use and provides input on data management reporting standards as required
    • Ensure accurate delivery by creating macros for Standard listings for the department based on specifications.
    • Creates and tests listings for data review.
    • Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests.
    • Ensures operational excellence in collaboration with partners and colleagues for application of standards and develop data cleaning reports in support of the data review plan, in collaboration with the Clinical Data Management
    • Directly supports knowledge development of others on data reporting and reporting tools that support the accuracy and integrity of study data
    • Identifies existing process/product improvements
    • Develops innovative, advanced new concepts that improve processes
    • Recognizes development needs and identifies/creates development opportunities within team
    • Supports the development of the Data Management Programming talent base and identifies development needs within the area of responsibility DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise
      • Comprehensive understanding of the pharmaceutical industry and programming expertise for data cleaning (e.g., clinical development, the prescription drug distribution process, etc.)
      • Technical expertise at the enterprise level, with a broader clinical data life cycle awareness
      • Excellent communication skills and ability to 'translate' across functional lines Leadership
        • 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 data management programming decision making
          • Participate in and/or lead initiatives that seek diverse input from multiple constituents and stakeholders to drive innovative solutions 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
            • 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
              • 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 data EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
                  • MS with -6+ years of industry related experience.
                  • BS with -8+ years of industry related experience.
                  • Proven track record of contributing to business process transformation and organizational culture change as well as providing programming expertise on programs with complex business deliverables
                  • Experience leading business process transformations and organizational culture change as well as contributing to programming expertise on programs with complex business deliverables
                  • Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.)
                  • Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable
                  • Strong communication (written and oral), leadership, decision-making, influencing, negotiation, and project management skills
                  • Demonstrated experience managing complex projects and developing successful partnerships within and across functional areas
                  • Technical skills and experience using relational databases (e.g. MS SQL Server, Redshift, or Oracle), SAS and data visualization tools (e.g. BOXI, Spotfire, Tableau, RShiny, JReview)
                  • EDC build and/or clinical data management experience preferred
                  • Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)
                  • Programming, specifically SAS and R, and other visualization tools hands-on experienceADDITIONAL INFORMATION
                    • Assists with quality review of above activities performed by a vendor, as needed.---
                    • Adhere to SOPs for computer system validation and all GCP (Good Clinical Practice) regulations.
                    • Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.---
                    • Performs other duties as assigned within timelines
                    • This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy. This level has potential for "Remote".Base Salary Range: $124,600 to $178,000, 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. 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, Elizabeth , Senior Manager, Programming, Executive , Elizabeth, New Jersey

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