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Sr. Principal/Associate Director, Statistics

応募後で応募 求人ID R0030862 掲載日 06/15/2021 Location:Boston, Massachusetts

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Job Description

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 a Senior Principal/Associate Director, Statistics, you will be empowered to 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. 

OBJECTIVES:  (Briefly summarize the overall purpose of the position.  Objectives should be written in 3 – 4 statements).

Drives statistical aspects of biomarker development for Takeda R&D assets for Oncology TA covering design and analysis from pre-clinical to early clinical studies.

  • Leads collaborations with preclinical, biomarker, translational and clinical scientists to enable data driven decision making.
  • Oversees exploratory statistics activities for one major clinical program or multiple clinical programs to ensure timely and accurate delivery of biomarker analysis plans, publications, reports and regulatory submissions.
  • 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 Oncology 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.

ACCOUNTABILITIES:  (Describe the primary duties and responsibilities of the job.  Approximately 5 – 10 task statements should be identified).

  • Serve as global statistical lead for biomarker development in Oncology TA.
  • Play a leadership role in development and completion of major statistics deliverables and milestones in collaboration with other functions.
  • 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 statistical leadership and support for internal decision making, regulatory meetings, submissions and follow up.
  • 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 such as ASA, PhRMA, DIA, etc. to identify industry best practice and its applicability in Takeda.

EDUCATION, EXPERIENCE AND SKILLS:  (List the education and experience required to perform the primary responsibilities of the job.  Equivalent combinations of education and experience should be noted).

  • PhD in statistics/biostatistics or in bioinformatics with an emphasis on statistics with at least 6 years of relevant industry experience or MS in statistics with at least 8 years of relevant industry experience.
  • Strong background in statistical programming in R or SAS with the ability to independently develop relevant programs
  • Demonstrated experience in biomarker discovery and development for Oncology TA with specific emphasis on immuno-oncology.
  • Expert knowledge of statistical approaches for assay development and validation, analysis of high-dimensional data utilizing Omics technologies, flow cytometry, multiplexed imaging data
  • Expert knowledge across broad the areas of statistical methodologies including subgroup analysis, longitudinal data analysis, predictive modeling, machine learning, Bayesian modeling
  • Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in the cross-functional interfaces with the Statistics function.
  • Strong statistical programming skills
  • Excellent oral and written communications skills.
  • Strong inter-personal and people management skills including interface with quantitative functions in industry.
  • Strong project management skills.
  • Strong collaborative skills and ability to work with a cross-functional team.
  • Ability to influence others, without direct hierarchical authority, and affect change across organizational boundaries. 

This job posting excludes CO applicants.

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Relocation Assistance
  • 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 Programs

                                       Empowering Our People to Shine

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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