Associate Director, GI Statistics

Company: Takeda Pharmaceutical
Location: Newark
Posted on: January 23, 2023

Job Description:

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Job Description

About the role: Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda.

Here, teamwork is everything. Drug discovery, design and development is increasingly more complex and every individual on the team matters to the success of our inspiring, bold mission. You are guaranteed to be a vital contributor to everyone's success, most importantly your own. As an Associate Director, Statistics, you will be empowered, and will have the opportunity to serve as scientific leader who will provide statistical leadership in the design, analysis, and interpretation of clinical and translational studies at both the compound and therapeutic area (TA) levels, promoting innovative designs and methodologies.

How you will contribute:

• Drives all statistical aspects of development for Takeda R&D assets for GI TA covering design and analysis from early clinical to registrational studies.
• Drives data driven decision making in multidisclipinary team environment by providing high level of statistical rigor to the analyses and interpretation of complex data generated.
• Independently provides strategic and expert statistical input to drug development including feasibility assessments, development plans, complex study designs, cross-study analyses including statistical methodology, interpretations, regulatory submissions and follow up.
• Establishes and drives GI TA programs functional strategy for resourcing, processes and standards to maximize efficiency and global data integratability.
• Participates in functional and cross functional initiatives including process and quality improvements.
• Serve as global statistical lead for GI TA. Provide statistical leadership and support for internal decision making, regulatory meetings, submissions and follow up.
• Review key program documents and presentations, attend meetings to develop a comprehensive overview of the existing data, form a deep understanding of the development rationale and strategy and the key questions that need to be answered from data, and help the teams identify any statistical shortfalls and propose solutions to overcome them
• Attend scientific conferences and stay abreast with the latest developments in GI
• Play a leadership role in development of Clinical Development Plans and completion of major statistics deliverables and milestones in collaboration with other functions
• Stay up-to-date on emerging technologies and associated data analytic techniques, external databases and novel methodologies that can help Takeda derive the maximum value out of data
• Drive/participate in development and implementation of global systems, processes and standards to maximize quality and efficiency.
• Leverage standardized analysis methods and reporting standards to maximize global data integratability; identifies best practice for utilization across programs.
• Provide or identify internal and external statistical expertise and capacity to support development activities. Collaborate/lead in the development of compound/program-level sourcing/vendor strategies and provide oversight of statistical services, ensuring overall quality. Assess, communicate and propose solutions for internal, external resource and/or quality issues that may impact deliverables/timeline at the program level. Provide input for planning and management of external budgets related to statistical deliverables.
• Active participation in external professional initiatives and organizations to identify industry best practice and its applicability in Takeda. Minimum Requirements/Qualifications:
  • PhD in statistics/biostatistics with an emphasis on statistics with at least 5 years of relevant industry experience or MS in statistics with at least 8 years of relevant industry experience
  • Team work is key for this role. Candidate will be expected to routinely interface with other functions in industry and must have strong inter-personal and people management skills, and ability to influence others, without direct hierarchical authority, to affect change across organizational boundaries.
  • Expert knowledge across broad areas of statistical methodologies including subgroup analysis, longitudinal data analysis, multivariate methods, predictive modeling, machine learning, Bayesian modeling. Strong background in statistical modeling in R or SAS with the ability to independently code relevant programs.
  • Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in the cross-functional interfaces with the Statistics function.
  • Excellent oral and written communications skills.
  • Strong project management skills. What Takeda can offer you:
    • Comprehensive Healthcare: Medical, Dental, and Vision
    • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
    • 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 and company match of charitable contributions
    • Family Planning Support
    • Flexible Work Paths
    • Tuition reimbursement Base Salary Range: $ 143,000 to $205,000 . 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, Newark , Associate Director, GI Statistics, Executive , Newark, New Jersey