Senior Manager, Programming

Company: Takeda Pharmaceutical
Location: Clifton
Posted on: May 19, 2023

Job Description:

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Job Description

OBJECTIVES/ PURPOSE

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 .

A CCOUNTABILITIES

• Be able to support PK programming needs for successful data reporting activities by providing hands on programming support .
• Deliver assigned projects with quality and timeliness
• Sets tasks and prioritization within their projects
• Support generat ion of NONMEM datasets for PK /PD analysis including maintenance of the variable definition file
• Deliver complex calculations with in NONMEM dataset build and PK modeling accordance of specification by partnering QCP colleagues .
• Create/QC NONMEM dataset(s) created by others/external programmers .
• Generate e-submission package for NONMEM (or other modelling type) analysis. (e.g., NONMEM control file, output parameter files, output table files and other files ) and maintain supportive documentations .
• Work and engage cross functionally to deliver PK/PD analysis and i nteract /communicate with external v endors in data collection, data formatting, data presentation .
• Lead cross departmental PK/PD data reporting trainings as needed.
• Experience with data plotting in R is desired ( e.g. ggplot2).
• Carry out functional responsibilities in accordance with applicable SOPs and Regulatory requirements
• Provide hands on Support internal decision making modelling tasks
  
  CORE ELEMENTS RELATED TO THIS ROLE
  • Provides technical s upport and ensures adequate statistical programming support for assigned projects
  • Contribute in cross-functional communication to establish future-fit internal data flow and processes
  • Support and provide programming activities for assigned P K/PD projects
  • Partner with QCP colleagues to ensure successful implementation of Statistical Programming strategies and efficient execution of the statistical analyses for the assigned P K/PD projects
  • Str ong communication skills to lead team discussions
  • Strong knowledge of CDISC data standard and regulatory submission activities
    DIMENSIONS AND ASPECTS
    
    Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of technical knowledge)
    • Comprehensive understanding of the pharmaceutical industry and statistical programming (e.g., clinical development, the prescription drug distribution process, etc.)
    • Excellent analytical, technical, and computer skills
    • Advanced SAS programming ability
    • Strong knowledge of CDISC standards, medical terminology, clinical trial methodologies, and FDA/ICH regulation Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)
      • Demonstrated ability to work across functions, regions and cultures
      • Excellent communicator, able to convey both ideas and data, verbally and in writing
      • Operate as an effective team player who can work engagingly with others
      • Ability to disti l complex technical programming ideas in s imple comprehensible terms
      • Embraces and demonstrates a diversity and inclusion mindset
      • Owns assigned tasks, identifies the need for and actively seeks input from others
      • Engages cross functionally to progress tasks by influencing
      • Leads activities and parts of projects including studies or exploratory work related to clinical drug R&D
      • Establishes internal and external presence on topics of interest Decision-making and Autonomy ( The capacity and authority to make organizational decisions , autonomy in decision-making, complexity of decisions, impact of decisions, problem- solving )
        • Provide input to strategic decisions that impact the statistical programming function
        • Accountable for statistical programming decision making within study level
        • Participate in initiatives that seek diverse input from multiple constituents and stakeholders to drive innovative solutions
          
          Interaction (The span and nature of one's engagement with others when performing one's job , internal and external relationships)
          • Effectively understands the changing external and internal environment
          • 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 lim i ted to statistics, data management, clinical operations Innovation (The required level of scientific knowledge, knowledge sharing, innovation and risk taking)
            • Comfortable ch alleng ing the status quo and bringing forward innovative solutions
            • Ability to recommend technical solutions using a wide variety of software ( e.g. SAS, R, Python)
            • Ability to communicate ideas around possible innovative solutions, and possibly ways to accelerate existing milestones Complexity ( Products managed, mix of businesses, internal and/or external business environment, cultural considerations )
              • Ability to work in a global ecosystem (internal and external) with a high degree of c om p l exity
              • Expertise required across statistical programming and computing environments
              • Ability to see and understand broader, enterprise level perspective
              • Awareness of best practices with data sharing
              • Awareness of programming input 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
                • 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
                  
                  ADDITIONAL INFORMATION
                  • This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
                  • Base Salary Range: $ 130,200.00 to $ 186,000.00 . Employees may also be eligible for Short Term and Long-Term Incentive benefits. 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.
                  • The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.
                    
                    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, Clifton , Senior Manager, Programming, Executive , Clifton, New Jersey